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var arCategories = new Array("Preclinical", "Clinical", "Pharmacovigilance", "Manufacturing and QC", "IT", "Regulatory Submissions", "Commercial", "Chemistry and Pharmacy");
var arRegions = new Array("USA", "Europe", "Other");
var arExperts = new Array();
var arModules = new Array();

var sStandardBenefit = "All staff in the pharmaceutical industry who are inexperienced in regulatory affairs and compliance will find the module an invaluable introductory training course. More experienced personnel will find it a useful reference tool.";

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oExpert.name = "This introductory module is maintained by Zenosis staff.";
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var oExpert = new ClsExpert();
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oExpert.image = "images/authors/verius.jpg";
oExpert.imageWidth = 100;
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oExpert.company = "Verius Ltd";
oExpert.link = "http://www.zenosis.com/links/weblinks/links.asp?gotolink=562";
oExpert.position = "";
oExpert.text = "This module is maintained by staff of Verius Ltd, a drug and healthcare product development service company, based in Cambridgeshire, UK, who offer support and consultancy in the development of medicinal products and medical devices worldwide. Verius are actively involved in all aspects of development from nonclinical studies to out-licensing.<br>";
arExperts[1] = oExpert;

var oExpert = new ClsExpert();
oExpert.name = "Dr Susan Chisholm";
oExpert.image = "images/authors/susan_chisholm.jpg";
oExpert.imageWidth = 100;
oExpert.imageHeight = 100;
oExpert.company = "Verius Ltd";
oExpert.link = "http://www.zenosis.com/links/weblinks/links.asp?gotolink=562";
oExpert.position = "Regulatory Affairs Officer";
oExpert.text = "<strong>Susan Chisholm</strong> has over 15 years of experience in the research and development of vaccines, gene therapy and other biotechnology products in both academia and the drug industry. She has a BSc in Pathology from Glasgow University and a PhD in Immunology and Virology from Cambridge University as well as a number of publications in leading scientific journals. Susan spent 7 years at Cantab Pharmaceuticals where she played a key role in getting products to the market. She currently works as a regulatory affairs officer for Verius Ltd, a drug and healthcare product development service company and is responsible for all their regulatory activities.";
arExperts[2] = oExpert;

var oExpert = new ClsExpert();
oExpert.name = "Dr Barbara Schnurr";
oExpert.image = "images/authors/barbara_schnurr.jpg";
oExpert.imageWidth = 100;
oExpert.imageHeight = 100;
oExpert.company = "Harrison Clinical Research Group";
oExpert.link = "http://www.zenosis.com/links/weblinks/links.asp?gotolink=554";
oExpert.position = "Quality Assurance Manager";
oExpert.text = "<strong>Barbara Schnurr</strong>, a certified Quality Systems Manager (European Organization for Quality, Brussels, Belgium / German Organization for Quality, Frankfurt, Germany) is the Chief Quality Assurance Manager at Harrison Clinical Research in Munich, Germany. Her responsibilities include performance of study audits, system audits, supplier audits, preparation and handling of Standard Operating Procedures, training of in-house and external personnel. She received her PhD in Dietetics, Oncology at the University of Vienna. She worked for four years as a research fellow in the intensive care and surgical unit of the University Clinic Mannheim/Heidelberg, and has been active in clinical research since 1995. Dr Schnurr began her clinical research career as a CRA. Under her leadership, Harrison Clinical Research's QA system has been built, and ISO9001 certified in 1998. Additionally, Dr Schnurr supervises the QA working group of the BVMA (Federal Association of German CROs).";
arExperts[3] = oExpert;

var oExpert = new ClsExpert();
oExpert.name = "Dr Stanley Garbus";
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oExpert.imageWidth = 100;
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oExpert.company = "";
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oExpert.position = "";
oExpert.text = "<strong>Stanley Garbus</strong> MD, MPH has more than two decades of experience across all phases of clinical research and safety surveillance.<br><br>Prior to founding Sentrx in 1995, Dr Garbus held senior clinical research management positions in several international pharmaceutical companies and contract research organisations. His achievements include implementing, managing, and reengineering adverse event tracking systems and providing crisis management consulting services, including an FDA Class I recall, and legal expertise to the pharmaceutical industry. An acknowledged expert in developing and implementing drug safety programmes, he is a frequent speaker and course leader at conferences and seminars.<br><br>Dr Garbus received an MD from the University of Geneva, Switzerland, and completed speciality training in Internal Medicine and Nephrology. He also received an MSc in Public Health from the Yale University School of Medicine, Department of Epidemiology and Public Health.";
arExperts[4] = oExpert;

var oExpert = new ClsExpert();
oExpert.name = "Dr Francisco Harrison";
oExpert.image = "images/authors/francisco_harrison.jpg";
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oExpert.company = "Harrison Clinical Research Group";
oExpert.link = "http://www.zenosis.com/links/weblinks/links.asp?gotolink=554";
oExpert.position = "Chairman";
oExpert.text = "<strong>Francisco Harrison</strong> holds a Medical Practitioner's licence for Spain, Germany and the United Kingdom. He was project manager at Cyanamid\Iberica SA, responsible for clinical research & development of new products (Phase III studies). He was Project Manager at the Iphar Institute for Clinical Pharmacology, Munich, responsible for Phase-I & pharmacodynamic studies. In 1983 Dr Harrison became an independent adviser to the Pharmaceutical Industry, undertaking in 1984-86 research projects for LFP Laboratory for Pharmacokinetics and Biopharmacy in Munich, in the planning of clinical studies, Phase I protocol development and monitoring. In 1986 he was scientific collaborator at the Ludwig Maximillian University, responsible for clinical projects in the Neuropharmacological Department of Munich University.<br><br>Since 1987 Dr Harrison has established 'The Harrison Clinical Research Group' in Germany, UK, Belgium and Israel. He has and continues to lecture globally and is author and co-author of some 50 international publications. Amongst others, Dr Harrison is a member of: Spanish Medical Council, Bavarian Medical Council, Society of Pharmaceutical Medicine (GB), Information Drug Association (USA), Association for Clinical Data Management (GB), American College of Clinical Pharmacology, and American Academy of Pharmaceutical Physicians.";
arExperts[5] = oExpert;

var oExpert = new ClsExpert();
oExpert.name = "Marion Alzer";
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oExpert.imageWidth = 100;
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oExpert.company = "Harrison Clinical Research Group";
oExpert.link = "http://www.zenosis.com/links/weblinks/links.asp?gotolink=554";
oExpert.position = "";
oExpert.text = "<strong>Marion Alzer</strong> MA holds a Diploma in Medical Translation from the University of Mainz, Germany and an MA in Linguistics from Louisiana State University, USA. Since 1991, Marion has been employed in pharmaceutical and clinical research companies in Germany. She first worked as medical translator for Lilly Deutschland and E Merck, and in 1995 joined Harrison Clinical Research in Munich. Following several years experience as Project Manager (Phase I-III), she now develops training material, quality-controls study reports, and writes and reviews Standard Operating Procedures for the Quality Assurance Department of Harrison Clinical Research. Marion is a member of the Deutsche Gesellschaft für Pharmazeutische Medizin (German Society for Pharmaceutical Medicine), and also DIA.";
arExperts[6] = oExpert;

var oExpert = new ClsExpert();
oExpert.name = "Dr Nira Garty";
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oExpert.imageWidth = 100;
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oExpert.company = "Harrison Clinical Research Group";
oExpert.link = "http://www.zenosis.com/links/weblinks/links.asp?gotolink=554";
oExpert.position = "";
oExpert.text = "<strong>Nira B Garty</strong> PhD holds a BSc in Chemistry and an MSc in Biochemistry. She was warded The Fogarty Scholarship for postdoctoral work at the NIDDK, NIH USA. In 1992, she became Assistant Director for Clinical and Regulatory Affairs at Pharmos Corp, and was involved in ophthalmic and neuro-protective drug development. In 1995 she joined MOR Research Application, a local CRO, as a  VP for clinical and Regulatory Affairs. In that capacity she was involved in protocol development, medical writing as well as active clinical trials. In 1997 and 1998 Dr Garty prepared and administered the first academic courses for management of clinical trials in collaboration with the external studies unit of Bar-Ilan University. In 1999, she joined Harrison Clinical Research as the Managing Director of the offices in Israel. She is a member of the Israeli Society for Biochemistry and Molecular Biology and The Israeli Society for Neuroscience. She was on the founding team of the Israeli Society for Management of Clinical Trials and is still serving on the management panel, and is also a member of the DIA (1993), the Society for Clinical Trials (1996) and ACRP (2000). and Dr Garty is the author or co-author of over 30 scientific publications.";
arExperts[7] = oExpert;

var oExpert = new ClsExpert();
oExpert.name = "Dr Hugh Delargy";
oExpert.image = "images/authors/hugh_delargy.jpg";
oExpert.imageWidth = 100;
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oExpert.company = "";
oExpert.link = "";
oExpert.position = "";
oExpert.text = "<strong>Hugh Delargy</strong> PhD is currently an independent pharmaceutical regulatory consultant. Prior to this he was a senior associate director in regulatory affairs with Pfizer Global Research and Development for a period of four years; a senior pharmaceutical assessor with the UK's Medicines Control Agency; a senior manager in pharmaceutical R&D for a division of Bristol-Myers Squibb, with a focus on the development of analytical methods, stability testing and formulation development.<br><br>Dr Delargy is also a visiting senior lecturer in pharmacy at Kings College, University of London and is a registered pharmacist.";
arExperts[8] = oExpert;

var oExpert = new ClsExpert();
oExpert.name = "Dr Emma Toumi";
oExpert.image = "images/authors/emma_toumi.jpg";
oExpert.imageWidth = 100;
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oExpert.company = "";
oExpert.link = "";
oExpert.position = "";
oExpert.text = "<strong>Emma Toumi</strong> MSc, PhD is a Licence and Patent Management Executive at Imperial College Innovations, London. She earned her PhD in Biotechnology from the University of Cambridge and in 1997 was awarded an Honorary Lectureship in Immunology at St George's Hospital Medical School. Dr Toumi received a scholarship to study an MSc in Management of Intellectual Property at Queen Mary College. Before joining Imperial College Innovations, she prosecuted patents and trade marks for three years in the intellectual property department of a City of London law firm. She has given lectures on intellectual property to students studying at the University of London and has several publications on biotechnology patents.";
arExperts[9] = oExpert;

var oExpert = new ClsExpert();
oExpert.name = "Dr Peter Schüler";
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oExpert.imageWidth = 100;
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oExpert.company = "";
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oExpert.position = "";
oExpert.text = "<strong>Peter Schüler</strong> MD is a Board certified neurologist and holds a degree in pharmaceutical medicine of the Swiss Medical Association (FMH).  He has over 17 years experience in clinical medicine and research and has worked in University hospitals, 'big pharma' and the CRO industry.  He currently lectures on pharmaceutical medicine at the University of Witten, Germany.";
arExperts[10] = oExpert;

var oExpert = new ClsExpert();
oExpert.name = "Dr Nermeen Varawalla";
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oExpert.company = "PRA International, UK.";
oExpert.link = "http://www.zenosis.com/links/weblinks/links.asp?gotolink=574";
oExpert.position = "Vice President Business Development, International";
oExpert.text = "<strong>Nermeen Y Varawalla</strong> MD, DPhil (Oxon), MBA leads the ex-US business development team at PRA International - a global CRO with 2700 employees, covering 68 countries in all six continents. Nermeen has a strong interest in the utilisation of emerging world countries for global clinical trials and is developing PRA's capabilities in Mumbai, India.<br><br>Prior to joining PRA, Nermeen was the founder of PerinClinical, a niche India focussed CRO. Before that she worked with Accenture's Business Strategy Consulting Practice specialising in the area of clinical development strategies and processes.<br><br>Nermeen received her medical training at the KEM group of hospitals, Mumbai, India. She was awarded the Rhodes Research Fellowship to Oxford University for her doctoral research and then practised as an NHS specialist. Nermeen obtained her MBA at INSEAD and is Chairman of the INSEAD Alumni Health & Pharma Group.";
arExperts[11] = oExpert;

var oExpert = new ClsExpert();
oExpert.name = "Dr Paul Derbyshire";
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oExpert.imageWidth = 100;
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oExpert.company = "Orphix Consulting GmBH";
oExpert.link = "http://www.zenosis.com/links/weblinks/links.asp?gotolink=575";
oExpert.position = "";
oExpert.text = "<strong>Paul Derbyshire</strong> PhD has over 15 years international regulatory experience in the development, manufacture and licensing of innovative products derived from biotechnological processes. He has a strong scientific background in molecular biology, possessing a BSc in Microbiology and Virology and a PhD in Microbial Genetics from Warwick University, England. His expertise covers the areas of oncology, infectious and immunological disease, haemophilia, infertility and osteoinductive therapies and encompasses recombinant proteins, vaccines, growth factors, cytokines, monoclonal antibodies, blood products and NCEs.";
arExperts[12] = oExpert;

var oExpert = new ClsExpert();
oExpert.name = "Dr Stephan de la Motte";
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oExpert.imageWidth = 100;
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oExpert.company = "Harrison Clinical Research Group";
oExpert.link = "http://www.zenosis.com/links/weblinks/links.asp?gotolink=554";
oExpert.position = "CMO (Chief Medical Officer)";
oExpert.text = "<strong>Stephan de la Motte</strong> MD is a physician with formal education and a postgraduate qualification in emergency medicine and medical biometrics. He worked in general practice, pharmacology & toxicology, and anaesthesia before switching to clinical research. He has 13 years of experience in PK/PD clinical studies for drug registration purposes.";
arExperts[13] = oExpert;

var oExpert = new ClsExpert();
oExpert.name = "Norman Sadler";
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oExpert.imageWidth = 100;
oExpert.imageHeight = 100;
oExpert.company = "Sadler Quality Ltd";
oExpert.link = "http://www.zenosis.com/links/weblinks/links.asp?gotolink=576";
oExpert.position = "";
oExpert.text = "<strong>Norman Sadler</strong> has extensive experience of Quality Systems, having spent 12 years in the Quality Assurance organisation of a large, multinational pharmaceutical company. The latter half of this time was spent interfacing with key strategic suppliers on a global scale.<br><br>Norman has performed internal and external audits, helped suppliers improve their GMP, quality systems and quality performance, and prepared suppliers for regulatory inspections.<br><br>He is now an independent Quality Consultant.";
arExperts[14] = oExpert;

var oExpert = new ClsExpert();
oExpert.name = "Dr Stephen Bentley";
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oExpert.imageWidth = 100;
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oExpert.company = "";
oExpert.link = "";
oExpert.position = "";
oExpert.text = "<strong>Stephen Bentley</strong> qualified in medicine from Manchester University in 1971, and held both academic and clinical posts there until 1979.  He joined the pharmaceutical industry in January 1980, initially as a pharmaceutical physician with Upjohn Limited, from where he joined Fisons plc, holding a variety of posts, eventually becoming Medical Director, International Operations.<br><br>In 1990, Dr Bentley moved to Japan as Director, Research, Development and Medical Division for Wellcome plc, where he was responsible for the successful registration of anticancer, antiviral, cardiovascular and immunological products.  From Wellcome he moved to take up a post as Research and Development Director, Fujisawa-Fisons kk until 1996, when he returned to the United Kingdom.<br><br>Dr Bentley is currently Chairman of Verius Limited, a regulatory and development consultancy, a director of Harrison Clinical Research Limited and founding director of ASB Associates Ltd, a healthcare consulting company with an interest in development strategy for Japan and the East Asian markets.<br><br>Dr Bentley is a Fellow of the Faculty of Pharmaceutical Physicians of the Royal College of Physicians of the United Kingdom and a Member of the Institute of Biology.";
arExperts[15] = oExpert;

var oExpert = new ClsExpert();
oExpert.name = "Jane Muir";
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oExpert.imageWidth = 100;
oExpert.imageHeight = 100;
oExpert.company = "Wirral Clinical Consultancy Ltd";
oExpert.link = "";
oExpert.position = "";
oExpert.text = "<strong>Jane Muir</strong> BSc (Hons) has over 18 years experience in clinical research gained within the CRO, Pharmaceutical and Biotech sectors. She has extensive experience in the planning and conduct of clinical trials across a wide range of therapeutic areas and phases of development as a CRA, Project Manager and Clinical Operations Manager. She has managed both field-based and office-based teams of CRAs and Project Managers and has responsibility for the training of new CRAs.<br><br>She now works as an independent clinical research consultant and clinical advisor and provides monitoring, project management and GCP training for a number of clients.";
arExperts[16] = oExpert;

var oExpert = new ClsExpert();
oExpert.name = "Dr Laura Brown";
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oExpert.imageWidth = 100;
oExpert.imageHeight = 100;
oExpert.company = "";
oExpert.link = "";
oExpert.position = "";
oExpert.text = "<strong>Laura Brown</strong> is an independent QA expert and training consultant in the pharmaceutical industry; she is also Director of the MSc in Clinical Research, School of Pharmacy, at the University of Cardiff, Wales. Dr Brown is an expert on QA processes, GCP, the EU Clinical Trial Directive and pharmaceutical project management. She runs many pharmaceutical training courses including how to prepare for inspection, GCP and pharmaceutical project management. Laura is also an author of several books including <em>A Practical Guide to the Clinical Trial Directive (2005)</em> and <em>Project Management for the Pharmaceutical Industry (2004)</em>";
arExperts[17] = oExpert;

var oExpert = new ClsExpert();
oExpert.name = "Albert Yehaskel";
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oExpert.imageWidth = 100;
oExpert.imageHeight = 100;
oExpert.company = "";
oExpert.link = "";
oExpert.position = "";
oExpert.text = "<strong>Albert Yehaskel</strong> has been in the pharmaceutical industry for over 37 years. He has an MSc in Organic Chemistry and an MBA in Economics and Finance.<br/><br/>Albert began his career in medicinal research, working for Schering-Plough Corporation, in the area of trisaccharide antibiotics: Gentamicin, Sisomicin and semi-synthetic antibiotics, replacing a natural sugar with a synthetic moiety to create new synthetic antibiotics. He subsequently gained additional research experience with CNS drugs and polypeptides.<br/><br/>Following this, he subsequently entered the area of Regulatory Affairs, international and domestic, gaining valuable global regulatory experience. He has worked for Lederle Laboratories (American Cyanamid) now known as Wyeth, Block Drug, Sanofi and Purdue Pharma. He devoted 20 years to Regulatory Affairs.<br/><br/>His last job was with Sankyo Pharma, a Japanese company, where he worked in Regulatory Affairs for 5 years, accomplishing such tasks as filing and obtaining approval of two electronic NDAs whose products (Benicar and Benicar/HCT) are currently on the market. He has also filed numerous IND applications. With regard to submissions, Albert enjoys and likes the challenge of electronic submissions, both for NDAs and INDs.<br/><br/>Albert currently works for a large, prominent, Osaka, Japan-based company, where he has challenged himself to apply his knowledge towards the submission and approval of several NDAs.<br/><br/>Albert has interacted with many divisions of the FDA, orchestrating and participating in teleconferences and face to face meetings. He also enjoys extra-curricular work. As a member of the Drug Information Association (DIA), he has organised over 14 conferences in the area of document management and Chemistry, Manufacturing and Controls for DIA. He has also lectured at several of these conferences.<br>";
arExperts[18] = oExpert;

var oExpert = new ClsExpert();
oExpert.name = "Michael Pierro";
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oExpert.imageWidth = 100;
oExpert.imageHeight = 100;
oExpert.company = "";
oExpert.link = "";
oExpert.position = "Independent Consultant";
oExpert.text = "<strong>Michael Pierro</strong> has over 35 years experience in clinical research and training. He provides consulting services to the Biotechnology, CRO and Pharmaceutical Industry in the areas of clinical operations (Standard Operating Procedures) and GCP/SOP training (live and Internet delivery).<br><br>Previously employed by Barnett International, Michael served as Director, Business Development, Consulting & Clinical Training, responsible for development and implementation of standard operating procedures, specialized training programmes and related consulting services. Clients include pharmaceutical and biotechnology companies, CROs, university medical centres and US federal government.   <br><br>Prior to joining Barnett International, Michael was Director of Global Training for Hoechst Marion Roussel's (Aventis) Global Clinical Quality Assurance Department. In this role, he directed all GCP, SOP and technical training programmes and activities within the company's central Drug Development Center and other development sites throughout the world. In previous roles with Hoechst Marion Roussel, he served as a Senior CRA, Manager of Phase IV Operations, and Chairperson of the SOP Steering Committee.";
arExperts[19] = oExpert;

var oExpert = new ClsExpert();
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oExpert.company = "Lightowler Associates";
oExpert.link = "http://www.zenosis.com/links/weblinks/links.asp?gotolink=577";
oExpert.position = "Partner";
oExpert.text = "<strong>Norah M Lightowler</strong> BPharm, LLB, MRPharmS, FTOPRA has wide experience in the pharmaceutical industry, including research, regulation as a Principal Pharmaceutical Assessor with the UK regulatory agency, and in regulatory affairs as Associate Director of European regulatory affairs with an international pharmaceutical company. In 1994 she established Lightowler Associates, an independent consultancy offering expert regulatory advice and support to pharmaceutical companies in or proposing to enter the European market for human pharmaceuticals. They offer a comprehensive regulatory service from strategic development, through registration to maintenance of marketing authorisations. Norah is experienced in organising and presenting courses on European regulatory systems, including requirements, procedures and strategy through both public and in-house training courses. The niche e-learning concept provided by Zenosis is a logical addition to training in the Life Science Industry.";
arExperts[20] = oExpert;

var oExpert = new ClsExpert();
oExpert.name = "Dr Bob Kapitany";
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oExpert.imageWidth = 100;
oExpert.imageHeight = 100;
oExpert.company = "Sendar-Menlha";
oExpert.link = "http://www.zenosis.com/links/weblinks/links.asp?gotolink=578";
oExpert.position = "CEO";
oExpert.text = "<strong>Robert Kapitany PhD</strong> has been a leader in the development of CANDAs, electronic submissions and eCTD for over 15 years.<br><br>He is one of the original members of the ICH M2 Expert Working Group for the electronic transmission of regulatory information and, as Ms EWG member, provided the technical expertise for the actual development of the eCTD DTD and specification.";
arExperts[21] = oExpert;

var oExpert = new ClsExpert();
oExpert.name = "Chris Brooks";
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oExpert.company = "QuadraMed Ltd.";
oExpert.link = "http://www.zenosis.com/links/weblinks/links.asp?gotolink=579";
oExpert.position = "Director of Regulatory Affairs";
oExpert.text = "<strong>Chris Brooks</strong> has held positions of responsibility in regulatory affairs since 1978 and founded the company, originally known as Chris Brooks Associates (CBA) in 1991, after 4 years as an independent consultant. He has a wide range of hands-on experience having worked with NCEs, generics, traditional biologicals including vaccines, recombinant DNA products, gene therapeutics and herbal medicines.";
arExperts[22] = oExpert;


//////////////////////////////////////// NEW PERSON HERE /////////////////////////////////////////



var oModule = new ClsModule();
oModule.code = "ESS01";
oModule.title = "Essentials of EU and US Regulatory Affairs for Human Medicinal Products";
oModule.description = "This foundation-level module is the ideal introduction for new entrants to the field of pharmaceutical regulatory affairs and compliance.  It describes the principal requirements that must be satisfied to gain and maintain approval to market medicinal products in the USA and Europe. The legal framework and the roles of major players in regulation are presented. The life-cycle of a drug is outlined. The various procedures available for assessment and approval of products are described and their requirements outlined. Obligations to be fulfilled after marketing approval are discussed. When changes to regulations and procedures occur, the module is updated and hence serves as a handy reference tool allowing new as well as experienced users to keep up to date with the broader picture of the regulatory affairs environment.";
oModule.status = STATUS_LIVE;
oModule.duration = 3;
oModule.level = 0;
oModule.objectives = "<ul><li>Describe the role and responsibilities of regulatory affairs within the pharmaceutical industry in both the EU and the USA.</li><li>Identify the main legislative instruments relating to medicinal products in both the EU and USA.</li><li>Understand the main phases of the drug development process and be aware of the regulatory requirements that apply.</li><li>Describe the requirements for applications for marketing approval and the procedures to be followed in both the EU and USA.</li><li>Identify post-marketing regulatory activities in both the EU and USA.</li></ul>";
oModule.benefit = sStandardBenefit;
oModule.addOutline("<b>Regulatory affairs primer</b><br>This session gives a definition of regulatory affairs and outlines the function and evolution of regulation in the pharmaceutical industry as well as providing a source of key legislation and guidelines. National and international regulatory authorities are introduced including the legal frameworks in the USA and EU.");
oModule.addOutline("<b>The life-cycle of a drug</b><br>This session looks at the main differences between types of medicinal products, outlines the discovery phase and nonclinical studies and gives a basic introduction to Good Laboratory Practice. It also identifies the four phases of clinical development and introduces some of the special difficulties associated with paediatric trials. ");
oModule.addOutline("<b>Registering a drug</b><br>This session looks at the regulatory requirements during the nonclinical studies phase as well as the salient points of Good Clinical Practice. It also introduces the regulatory processes involved in gaining marketing authorisation in the EU and the USA. The session also introduces the learner to orphan drugs, line extensions, generics, naming conventions and compassionate use.");
oModule.addOutline("<b>After marketing approval</b><br>This session explores post-marketing approval activities, including variations and supplements, line extensions and pharmacovigilance, GMP, basic patent law in the EU and USA, marketing issues, advertising and generics.");
oModule.addOutline("<b>Summary</b><br>Key point summary for all topics covered in the module. Ideal for a refresher or consolidation of learning points.");
oModule.addOutline("<b>Assessment</b><br>Multiple-choice mastery assessment.");
oModule.addExpert(0);
oModule.addCategory(0);
oModule.addCategory(1);
oModule.addCategory(2);
oModule.addCategory(3);
oModule.addCategory(4);
oModule.addCategory(5);
oModule.addCategory(6);
oModule.addCategory(7);
oModule.audience = "Regulatory";
oModule.region = "USA, Europe";
arModules[arModules.length] = oModule;

var oModule = new ClsModule();
oModule.code = "SUB01";
oModule.title = "Orphan Drug Applications in the EU and USA";
oModule.description = "Orphan drugs are those for relatively rare indications. Special procedures and incentives apply to their registration, to encourage pharmaceutical companies to develop them. This module provides information necessary to enable the preparation of applications for orphan drug status in the EU and USA. The procedures for making an application are detailed, including the collection of supporting data and the acquisition of protocol assistance. In Europe the Centralised Procedure is now the mandatory route to gain marketing authorisation for orphan products. This module will serve as a useful reference tool to keep abreast of the impact of the new regulatory requirements.";
oModule.status = STATUS_LIVE;
oModule.duration = 2.5;
oModule.level = 1;
oModule.objectives = "<ul><li>Describe the advantages of orphan drug status in the EU and USA.</li><li>Explain how to prepare applications for orphan drug designation in the EU and USA.</li><li>Understand the approval process for orphan designation in the EU and USA and how to proceed if orphan designation is refused.</li></ul>";
oModule.benefit = sStandardBenefit;
oModule.addOutline("<b>Overview</b><br>This brief session introduces the concept of orphan drugs, what they are and why they exist. It also identifies the criteria for orphan designation and gives a high level overview of the process of orphan designation and development.");
oModule.addOutline("<b>US designation</b><br>This session provides an understanding of the characteristics of orphan drug designation and the commercial advantages associated with the development of orphan drugs in the USA.");
oModule.addOutline("<b>US procedure</b><br>An application for orphan product designation in the USA has to be made to the Office of Orphan Products Development. Although there is no formal structure to the application, the FDA has a nine-point checklist of requirements which must be addressed by the sponsor. This session will provide information on each item of the list, the duration of the review, what happens after successful designation, and what to do if your application is refused.");
oModule.addOutline("<b>EU designation</b><br>This session will explain the definition of an orphan product in the European Union and describe the role of the European Medicines Agency and the Committee for Orphan Medicinal Products.");
oModule.addOutline("<b>EU procedure</b><br>Applications for orphan status within the EU are made to the EMEA, and the Committee for Orphan Medicinal Products assesses the application. This session will describe how to make an application for orphan medicinal product designation to the EMEA, what to do after approval is received, and how to make an appeal if you receive a negative opinion.");
oModule.addOutline("<b>Assessment</b><br>Multiple-choice mastery assessment.");
oModule.addExpert(1);
oModule.addCategory(5);
oModule.audience = "Regulatory";
oModule.region = "USA, Europe";
arModules[arModules.length] = oModule;

var oModule = new ClsModule();
oModule.code = "SUB02";
oModule.title = "The European Centralised Procedure (CP)";
oModule.description = "The CP is one of three routes available to applicants to gain multinational marketing authorisation within the European Economic Area (EEA). In the CP, one successful application leads to a licence being issued by the European Commission that applies throughout the EEA. The CP is mandatory for certain types of products.<br><br>This module describes the various players in the procedure, the sequence and duration of the stages involved, and the requirements on content, format and timing of submissions.";
oModule.status = STATUS_LIVE;
oModule.duration = 1.5;
oModule.level = 2;
oModule.objectives = "<ul><li>Provide an overview of the CP process</li><li>Identify which products may/must use the CP</li><li>For products for which the CP is optional, outline the advantages and disadvantages of the CP compared with other routes to marketing authorisation</li><li>Describe requirements on content, format and timing of submissions</li><li>Specify the sequence and duration of the stages of the CP and the responsibilities of the participants</li><li>Describe the role of the European Medicines Agency and its relevant competent committee</li><li>Outline fast-track provisions</li><li>Describe the appeals procedure</li></ul>";
oModule.benefit = "This module is primarily aimed at Regulatory Affairs professionals dealing with Marketing Authorisation Applications and related submissions for regulatory approval in Europe.";
oModule.addOutline("<b>Overview</b><br>Provides an overview of the content of the module and outlines related Zenosis modules.");
oModule.addOutline("<b>Introduction</b><br>This session provides background information. It specifies the types of product for which the CP is mandatory and those for which it is optional. It discusses the types of Marketing Authorisation Application, and characteristics of the application procedure");
oModule.addOutline("<b>Procedure</b><br>This session takes you through the entire process from pre-submission to what happens after an Opinion has been received. It describes the actions required of the applicant and of the European Medicines Agency's competent committee");
oModule.addOutline("<b>Advice</b><br>This optional session describes the scientific advice process and provides details on how to obtain advice from the EMA's Scientific Advice Working Party and the Paediatric Committee");
oModule.addOutline("<b>Assessment</b><br>Multiple-choice mastery assessment.");
oModule.addExpert(1);
oModule.addCategory(5);
oModule.audience = "Regulatory";
oModule.region = "Europe";
arModules[arModules.length] = oModule;

var oModule = new ClsModule();
oModule.code = "SUB03";
oModule.title = "The Mutual Recognition Procedure (MRP)";
oModule.description = "The Mutual Recognition Procedure is one of three routes available to applicants to gain multinational Marketing Authorisation within the European Economic Area (EEA). A national licence is converted to harmonised licences issued in a number of other member states chosen by the applicant.<br><br>The MRP is similar to the Decentralised Procedure but with later involvement of the Concerned Member States in the assessment by the Reference Member State. The Coordination Group for Mutual Recognition and Decentralised Procedures provides guidance and acts to facilitate agreement among the participating states.<br><br>This module describes the roles of the various players in the procedure, the sequence and duration of the stages involved, and the requirements on content, format and timing of submissions. It discusses the special issues that apply to generic products in the MRP.";
oModule.status = STATUS_LIVE;
oModule.duration = 2.0;
oModule.level = 1;
oModule.objectives = "<ul><li>Provide an overview of the MRP process</li><li>Describe the pre-submission and submission actions in relation to timeline deadlines</li><li>Specify the responsibilities of the Reference Member State (RMS), the Concerned Member States (CMSs) and the applicant</li></ul>";
oModule.benefit = "This module is primarily aimed at Regulatory Affairs professionals dealing with Marketing Authorisation Applications and related submissions for regulatory approval in Europe.";
oModule.addOutline("<b>Overview</b><br>Provides an overview of the content of the module and outlines related Zenosis modules.");
oModule.addOutline("<b>Introduction</b><br>This session provides background information. It covers products for which the MRP can be used, the types of Marketing Authorisation Application, and characteristics of the application procedure.");
oModule.addOutline("<b>The MRP process</b><br>This session takes you through the entire process from initial national authorisation by the RMS to the issuing of national licences by the CMSs. Referral of issues to the CMD, and the arbitration process, are also covered.");
oModule.addOutline("<b>Generics and the MRP</b><br>This session gives a brief introduction to generics and the special issues that apply to generic products in the MRP.");
oModule.addOutline("<b>Assessment</b><br>Multiple-choice mastery assessment.");
oModule.addExpert(1);
oModule.addCategory(5);
oModule.audience = "Regulatory";
oModule.region = "Europe";
arModules[arModules.length] = oModule;

var oModule = new ClsModule();
oModule.code = "SUB04";
oModule.title = "Preparing Submissions in the Common Technical Document (CTD) Format";
oModule.description = "The CTD is the mandatory format for regulatory submissions in the European Union, Japan and Australia and strongly recommended in the USA and Canada. It is accepted widely elsewhere. This module explains the rationale for the CTD and provides guidance on its structure and format and the ways in which it is used.";
oModule.status = STATUS_LIVE;
oModule.duration = 2;
oModule.level = 2;
oModule.objectives = "<ul><li>Explain the rationale for the CTD, and describe the ways in which it is used</li><li>Identify regional differences in regulatory requirements for information in a CTD-formatted submission</li><li>Describe the structure of the CTD</li><li>Access guidance on detailed structure and content of the CTD</li><li>Outline formatting requirements for a CTD dossier</li><li>Describe co-production of a CTD dossier in paper and electronic form</li><li>Convert EU NTA and US NDA section codes and headings to their CTD equivalents</li></ul>";
oModule.benefit = "Regulatory affairs and compliance staff, and all those involved in drug development and who contribute to regulatory submissions, will find the module an invaluable introductory training course and/or a useful reference tool. Specialists in data handling, knowledge management or documentation will also wish to familiarise themselves with its contents.";
oModule.addOutline("<b>Introduction</b><br>This session introduces you to the nature of the Common Technical Document (CTD), a global standard designed by the ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use).  The composition of a regulatory submission team is outlined.");
oModule.addOutline("<b>Coarse Structure</b><br>In this session you will become more familiar with the five modules of the CTD.");
oModule.addOutline("<b>Fine structure and format</b><br>You will be given access to guidelines that specify in detail the structure of each module of the CTD and the relationship between their sections and the documents that make up a dossier. Recommendations are also given on how to segregate and paginate documents and how to format pages, tables of contents and cross-references.");
oModule.addOutline("<b>Using the CTD</b><br>Different ways in which you can use the CTD in practice are described. Information on requirements for updating and reformatting non-CTD dossiers on marketed products is provided.");
oModule.addOutline("<b>Co-production of the CTD and eCTD</b><br>Production of a CTD dossier in both paper and electronic format is outlined.");
oModule.addOutline("<b>Tools</b><br>Two tools allow you to convert section headings in the old EU NTA format or the US NDA format to their equivalents in the CTD.");
oModule.addOutline("<b>Assessment</b><br>Multiple-choice mastery assessment.");
oModule.addExpert(1);
oModule.addCategory(5);
oModule.audience = "Regulatory";
oModule.region = "USA, Europe, Other";
arModules[arModules.length] = oModule;

var oModule = new ClsModule();
oModule.code = "SUB05";
oModule.title = "Electronic Common Technical Document (eCTD)";
oModule.description = "The eCTD specification has been developed to facilitate the global electronic submission, review and lifecycle management of registration dossiers. It broadens the scope of the CTD to include information on variations, renewals and amendments, so that it is no longer a static document but is updatable throughout the life of the product. This module details the eCTD specification, discusses the approach to regional differences in dossiers, and provides guidance on creation of an eCTD submission. This relatively new aspect of submissions will undergo rapid and significant change as specifications are modified and refined further. The eCTD module is an excellent reference and training tool and will assist anyone involved with electronic submissions in navigating these changing requirements.";
oModule.status = STATUS_LIVE;
oModule.duration = 2.5;
oModule.level = LEVEL_FI;
oModule.objectives = "<ul><li>Describe the structure, requirements and functionality of the eCTD.</li><li>Outline XML basics and the architecture of the eCTD</li><li>Discuss Document Type Definitions (DTDs)</li><li>Explain how to build an eCTD</li><li>Specify regional differences</li><li>Discuss life cycle and change management</li><li>List criteria that will make an electronic application technically valid</li><li>Initiate electronic transfer to a regulatory authority.</li><li>Create, submit and maintain an eCTD dossier throughout the life of a drug product</li></ul>";
oModule.benefit = "This module is an essential tool for regulatory affairs and compliance staff and specialists in data handling, knowledge management or documentation. Project managers and experienced drug development staff who contribute to regulatory submissions will also wish to familiarise themselves with its contents.";
oModule.addOutline("<b>Introduction</b><br>This session defines the eCTD and identifies advantages of using this submission format.");
oModule.addOutline("<b>Technical infrastructure</b><br>This session gives information on XML specification and style sheets and describes the eCTD backbone.");
oModule.addOutline("<b>Directory structure</b><br>This session looks at the eCTD hierarchy, life cycle management and structure of the five modules.");
oModule.addOutline("<b>Submitting an eCTD</b><br>This session explores the workflow around planning and submitting an eCTD – particularly setting up the modules, migrating and validating the data, preparing the covering letter and submitting some eCTD parts on paper. It also reminds learners that a correctly completed eCTD is a valid legal document.");
oModule.addOutline("<b>Additional DTDs</b><br>Canadian, EU, Japanese, American and STF DTDs are described.");
oModule.addOutline("<b>Tools</b><br>This session includes a case study and an eCTD Checklist to assist learners when compiling an eCTD submission.");
oModule.addOutline("<b>Summary</b><br>Key point summary for all topics covered in the module. Ideal for a refresher or consolidation of learning points.");
oModule.addOutline("<b>Assessment</b><br>Multiple-choice mastery assessment.");
oModule.addExpert(21);
oModule.addCategory(4);
oModule.addCategory(5);
oModule.audience = "Regulatory";
oModule.region = "USA, Europe, Other";
arModules[arModules.length] = oModule;

var oModule = new ClsModule();
oModule.code = "SUB06";
oModule.title = "Variations to Marketing Authorisations in Europe";
oModule.description = "Changes to the terms of marketing authorisations for medicinal products, called variations in Europe, must be notified to or approved by the relevant regulatory authorities. Variations include changes to the composition of products, their manufacturing processes, the way they are used, or the indications for which they are authorised. Common approaches are adopted within the European Economic Area to variations to licences approved through the Centralised, Decentralised or Mutual Recognition Procedures. Recent legislation has substantially modified the regulatory requirements and extended them to purely national authorisations by member states. This module, which is fully up to date with the new legislation, covers the classification of variations into their several types and the regulatory requirements, guidance and procedures to be followed for each type.";
oModule.status = STATUS_LIVE;
oModule.duration = 3.5;
oModule.level = 2;
oModule.objectives = "<ul><li>Define the concept of variations to marketing authorisations in the EEA.</li><li>Identify which type of variation is appropriate for each kind of change to be made.</li><li>Identify the documentation required to support the variation.</li><li>Describe how to prepare and submit variation notifications or applications appropriate for each type of variation and route of regulatory approval, including options for grouping of variations and for worksharing of assessment.</li></ul>";
oModule.benefit = "Regulatory affairs and compliance staff, and all those who contribute to regulatory submissions, will find the module an invaluable introductory training course and/or a useful reference tool.";
oModule.addOutline("<b>Defining variations</b><br>This session identifies and characterises the different types of variation.");
oModule.addOutline("<b>Determining variation types</b><br>This session looks at the reasons for variations and describes how to identify the type of variation appropriate for each change required.");
oModule.addOutline("<b>General procedural aspects</b><br>This session describes the different routes to regulatory approval of variations, identifies which is appropriate for a given product, specifies the supporting documentation necessary, and describes the new provisions for grouping multiple variations into a single submission and for worksharing of regulatory assessment among member states.");
oModule.addOutline("<b>Variations via the Centralised Procedure</b><br>This session describes the processes specific to the submission and processing of variations notifications and applications through the Centralised Procedure.");
oModule.addOutline("<b>Variations via the Mutual Recognition Procedure</b><br>This session describes the processes specific to the submission and processing of variations notifications and applications through the Mutual Recognition Procedure.");
oModule.addOutline("<b>Case study</b><br>A case study of a flawed submission process.");
oModule.addOutline("<b>The new legislation</b><br>An outline of the changes brought about by Regulation (EC) 1234/2008 and Directive 2009/53/EC.");
oModule.addOutline("<b>Assessment</b><br>Multiple-choice mastery assessment.");
oModule.addExpert(20);
oModule.addCategory(5);
oModule.audience = "Regulatory";
oModule.region = "Europe";
arModules[arModules.length] = oModule;

var oModule = new ClsModule();
oModule.code = "SUB07";
oModule.title = "Registration of Monoclonal Antibodies";
oModule.description = "The production and use of monoclonal antibodies (mAbs) in the in-vivo diagnosis and treatment of human diseases has evolved exponentially in recent years.<p>This module identifies the key manufacturing issues and the concerns associated with mAb production. Setting of specifications is also discussed. Requirements on preclinical and clinical studies are set out. Special requirements for radio-labelled mAbs are described. Procedures for making regulatory submissions for mAbs are detailed: marketing authorisation application through the Centralised Procedure (CP) in Europe, and by a Biologics License Application (BLA) in the USA. Orphan drug status and its effect on clinical design are addressed. The module discusses the impact of recent developments in production techniques on the regulatory landscape and will serve as an effective reference source on future developments and their practical consequences.";
oModule.status = STATUS_LIVE;
oModule.duration = 3;
oModule.level = 2;
oModule.objectives = "<ul><li>Identify the regulatory requirements and pathways to licensure in the EU and USA.</li><li>Recognise and apply the relevant studies and developmental aspects to be conducted, critical to establishing safe and effective mAb products.</li></ul>";
oModule.benefit = "Individuals working on the research and development of monoclonal antibodies, on clinical trials, in regulatory affairs, or otherwise involved in the preparation of regulatory submissions. Those needing to improve their understanding of monoclonal antibodies for registration will find this module invaluable.";
oModule.addOutline("<b>Orientation</b><br>Designed as an introduction to using the Zenosis modules, this session guides you through the different functions of the module interface - such as how to navigate and interact with the course material. Also provided are five short tips on how to get the most from your e-learning experience.");
oModule.addOutline("<b>Overview</b><br>This session briefly describes the regulatory pathways to licensure in the EU and US.");
oModule.addOutline("<b>EU marketing approval</b><br>This session considers the regulatory requirements and pathways that are essential for marketing approval in the EU.");
oModule.addOutline("<b>US marketing approval</b><br>This session considers the regulatory requirements and pathways that are essential for marketing approval in the USA.");
oModule.addOutline("<b>Manufacturing issues</b><br>This session discusses key manufacturing issues in the development of mAb products.");
oModule.addOutline("<b>Setting specifications</b><br>This session outlines the tests conducted and appropriate acceptance criteria or test results required to establish specifications to which a drug substance and drug product should conform to be considered acceptable for use in humans.");
oModule.addOutline("<b>Preclinical issues</b><br>This session discusses key preclinical issues in the development of mAb products.");
oModule.addOutline("<b>Clinical issues</b><br>This session emphasises developmental aspects crucial to the creation of safe and effective mAb products.");
oModule.addOutline("<b>Radio-labelled mAbs</b><br>This session identifies the investigational studies on mAbs essential for successful marketing authorisation.");
oModule.addOutline("<b>MAbs as orphan drugs</b><br>This session provides a basic understanding of the concepts which apply to the registration of mAbs in the European Union and USA.");
oModule.addOutline("<b>Key point summary</b><br>Key point summary for all topics covered in this module. Ideal for review, a refresher or consolidation of learning points.");
oModule.addOutline("<b>Assessment</b><br>Multiple-choice mastery assessment.");
oModule.addExpert(12);
oModule.addCategory(0);
oModule.addCategory(1);
oModule.addCategory(3);
oModule.addCategory(5);
oModule.addCategory(7);
oModule.audience = "Regulatory, Compliance, Other";
oModule.region = "USA, Europe, Other";
arModules[arModules.length] = oModule;

var oModule = new ClsModule();
oModule.code = "SUB08";
oModule.title = "The ANDA: Requirements for Obtaining FDA Approval for a Generic Product in the USA";
oModule.description = "This course describes FDA expectations of applications for the licensing of generic products. It provides the background knowledge to effectively plan, gather and assemble the necessary documentation for the submission of an Abbreviated New Drug Application (ANDA). <br><br>Practical advice in the form of checklists is provided, and timelines are set out. The ANDA process is compared and contrasted with that for the NDA.";
oModule.status = STATUS_LIVE;
oModule.duration = 3;
oModule.level = 2;
oModule.objectives = "<ul><li>Outline the FDA generic drug approval system.</li><li>Describe the differences between the generic drug approval process and the new drug approval process.</li><li>Identify information contained in the 'Orange Book'.</li><li>Describe the methodology for determining bioequivalence of drug products.</li><li>Explain how to develop and submit a successful ANDA.</li></ul>";
oModule.benefit = "This module will provide you with up-to-date knowledge about the preparation and submission of the US ANDA. Focusing on the regulatory requirements regarding the format and content described in the Food and Drug Administration regulations and guidelines, the module describes the role of the FDA in the generic drug approval process, and how to develop and submit a successful ANDA.<br><br>Regulatory affairs and compliance staff, and all those who contribute to regulatory submissions, will find the module valuable as both a training resource and practical reference tool.";
oModule.addOutline("<b>Orientation</b><br>Designed as an introduction to using the Zenosis modules, this session guides you through the different functions of the module interface - such as how to navigate and interact with the content material. Also provided are five short tips on how to get the most from your e-learning experience.");
oModule.addOutline("<b>Regulatory overview</b><br>Module scope and objectives, areas not covered, and the US legislative framework.");
oModule.addOutline("<b>Generic Drugs and the ANDA</b><br>In this session a high level overview of the requirements and processes necessary to gain successful FDA approval are provided.");
oModule.addOutline("<b>Patent certification</b><br>This session distinguishes the different types of patent classification that can be submitted as part of an ANDA, what happens when a generic patent is challenged, and the exclusivity open to a generic company.");
oModule.addOutline("<b>The Orange Book</b><br>How to query the electronic Orange Book, and the searches necessary to extract the relevant information to assist in an application are covered in this session.");
oModule.addOutline("<b>Bioequivalence</b><br>This session explores the purpose of bioequivalence and its importance for approving an ANDA. It covers the terminologies of therapeutic equivalents, pharmaceutical equivalents and pharmaceutical alternatives, and defines what a bioequivalent drug product is.");
oModule.addOutline("<b>The ANDA submission</b><br>The format and content of the ANDA (traditional, CTD, and eCTD) with reference to 21 CFR are presented in this session.");
oModule.addOutline("<b>The ANDA review and approval process</b><br>This session delves deep into the FDA review and approval process and covers the common issues, requirements and guidance for a successful initial submission.");
oModule.addOutline("<b>Assessment</b><br>Multiple-choice mastery assessment.");
oModule.addExpert(18);
oModule.addCategory(5);
oModule.audience = "Regulatory, Compliance";
oModule.region = "USA";
arModules[arModules.length] = oModule;


var oModule = new ClsModule();
oModule.code = "SUB09";
oModule.title = "The NDA Process: Requirements for Obtaining Approval for a New Drug in the USA";
oModule.description = "A New Drug Application (NDA) is a regulatory vehicle through which Sponsors formally propose that the FDA approve a new drug for sale and marketing in the USA. <br/><br/>For successful FDA approval, what content and format requirements are necessary to comply with FDA guidelines? How do you plan your submission timetable?<br/><br/>This module provides regulatory professionals with the requirements to complete and submit NDAs for FDA approval.";
oModule.status = STATUS_LIVE;
oModule.duration = 3;
oModule.level = 2;
oModule.objectives = "<ul><li>Outline the format and content requirements of a New Drug Application (NDA).</li><li>Outline the necessary forms required for an NDA application.</li><li>Review an NDA via a checklist prior to submitting it to the FDA.</li><li>Summarise the role of the FDA in the NDA review and approval process.</li><li>Define the programmes implemented by the FDA to expedite the drug development and approval process.</li></ul>";
oModule.benefit = "This module is primarily aimed at regulatory professionals who are new to the New Drug Application (NDA) process. It will also benefit professionals in clinical research, data processing, project management and marketing, and whose role involves interaction with the Food and Drug Administration (FDA).";
oModule.addOutline("<b>Orientation</b><br>Designed as an introduction to using the Zenosis modules, this session guides you through the different functions of the module interface – such as how to navigate and interact with the content material. Also provided are five short tips on how to get the most from your e-learning experience.");
oModule.addOutline("<b>Overview</b><br>Provided in this session is information on the module: the scope, the areas not covered, module objectives and US legislative framework. The background and history of NDAs is also included in this session.");
oModule.addOutline("<b>NDAs: Content and formatting</b><br>This session provides an overview of the fundamental content and format requirements of an NDA for submission to the FDA. The four sessions that follow describe requirements for specific sections of the NDA.");
oModule.addOutline("<b>Chemistry, Manufacturing and Controls (CMC) information</b><br>The CMC information that must be detailed in the application is described in this session.");
oModule.addOutline("<b>Nonclinical information</b><br>The nonclinical information that must be detailed in an NDA is described in this session.");
oModule.addOutline("<b>Clinical and statistical information</b><br>This session provides an overview of the content and format requirements of the NDA's clinical data section.");
oModule.addOutline("<b>Administrative information</b><br>The content and format requirements of the index, labelling and application summary are addressed in this session.");
oModule.addOutline("<b>NDA review and approval process</b><br>In this session, the review and approval process, and the FDA’s role and actions in it, are described.");
oModule.addOutline("<b>Accelerated approval options</b><br>The FDA offers expedited approval programmes for drugs designed to treat serious or life-threatening conditions that demonstrate the potential to address unmet medical needs. These programmes are discussed in this session.");
oModule.addOutline("<b>Key point summary</b><br>Key point summary for all topics covered in this module. Ideal for review, a refresher or consolidation of learning points.");
oModule.addOutline("<b>Assessment</b><br>Multiple-choice mastery assessment.");
oModule.addExpert(18);
oModule.addCategory(5);
oModule.audience = "Regulatory";
oModule.region = "USA";
arModules[arModules.length] = oModule;

var oModule = new ClsModule();
oModule.code = "SUB10";
oModule.title = "Supplemental NDAs and ANDAs";
oModule.description = "When a new drug obtains marketing approval, it enters into another stage of the drug development cycle, to which different regulatory requirements must be complied with.<br><br>Although a drug product has been approved, the Food and Drug Administration (FDA), as a health protection agency, has continuous responsibility to monitor the safety of new drug products, as well as the new drug application (NDA) holder, who must also fulfil post-approval responsibilities.<br><br>This module will provide learning to holders of NDAs and abbreviated new drug applications (ANDAs) who intend to make post-approval changes to regulatory submissions.";
oModule.status = STATUS_FUTURE;
oModule.duration = 2;
oModule.level = 2;
oModule.objectives = "Outline the reporting categories for supplemental NDAs and ANDAs.<br>Distinguish between major, moderate and minor post-approval changes for specifications, manufacturing, indications and labelling supplements.<br>Summarise the requirements of major, moderate and minor post-approval submissions.";
oModule.benefit = "This module is primarily aimed at personnel in the pharmaceutical, biotechnology and generic drug industry who are involved in preparing Food and Drug Administration (FDA) submissions. This module will benefit professionals including Project Managers, Regulatory Affairs, non-clinical and clinical research, manufacturing and quality personnel, and staff whose role involves interaction with the FDA.<br><br>Professionals, who desire a greater understanding of writing regulatory submission applications in order to ensure compliance with regulatory filings, will find this module valuable.";
oModule.addOutline("<b>Orientation</b>");
oModule.addOutline("<b>Overview</b>");
oModule.addOutline("<b>Post-marketing requirements</b>");
oModule.addOutline("<b>Specifications supplements</b>");
oModule.addOutline("<b>Manufacturing supplements</b>");
oModule.addOutline("<b>Indication (Efficacy) supplements</b>");
oModule.addOutline("<b>Labelling supplements</b>");
oModule.addOutline("<b>Submission requirements</b>");
oModule.addOutline("<b>Assessment</b>");
//oModule.addExpert(18);
oModule.addCategory(5);
oModule.audience = "Regulatory";
oModule.region = "USA";
arModules[arModules.length] = oModule;

var oModule = new ClsModule();
oModule.code = "SUB11";
oModule.title = "The Decentralised Procedure (DCP)";
oModule.description = "The DCP is one of three routes available to applicants to gain multinational marketing authorisation within the European Economic Area (EEA). It can be used only for a product which has no existing marketing authorisation in any member state.<br><br>It is similar to The Mutual Recognition Procedure (MRP) but with earlier involvement of the Concerned Member States in the assessment by the Reference Member State. The Coordination Group for Mutual Recognition and Decentralised Procedures (CMD) provides guidance and acts to facilitate agreement among the participating states.<br><br>This module describes the roles of the various players in the procedure, the sequence and duration of the stages involved, and the requirements on content, format and timing of submissions. It discusses the special issues that apply to generic products in the DCP.";
oModule.status = STATUS_LIVE;
oModule.duration = 2;
oModule.level = 2;
oModule.objectives = "<ul><li>Provide an overview of the DCP process.</li><li>Describe the pre-submission and submission actions in relation to timeline deadlines.</li><li>Specify the responsibilities of the Reference Member State (RMS), the Concerned Member States (CMSs) and the applicant.</li></ul>";
oModule.benefit = "This module is primarily aimed at Regulatory Affairs professionals dealing with Marketing Authorisation Applications and related submissions for regulatory approval in Europe.";
oModule.addOutline("<b>Overview</b><br>Provides an overview of the content of the module and outlines related Zenosis modules.");
oModule.addOutline("<b>Introduction</b><br>This session provides background information. It covers products for which the DCP can be used, the types of Marketing Authorisation Application, and characteristics of the application procedure.");
oModule.addOutline("<b>DCP Step 1</b><br>This session takes you through the pre-procedural step and the first assessment stage of the DCP, as far as day 120.");
oModule.addOutline("<b>DCP Step 2</b><br>This session takes you through the second assessment stage and the final step of issuing national licences. Referral of issues to the CMD, and the arbitration process, are also covered.");
oModule.addOutline("<b>Generics and the DCP</b><br>This session gives a brief introduction to generics and the special issues facing generics in the DCP.");
oModule.addOutline("<b>Assessment</b><br>Multiple-choice mastery assessment.");
oModule.addExpert(22);
oModule.addCategory(5);
oModule.audience = "Regulatory";
oModule.region = "Europe";
arModules[arModules.length] = oModule;

/*SPARE MODULE
var oModule = new ClsModule();
oModule.code = "";
oModule.title = "";
oModule.description = "";
oModule.status = STATUS_LIVE;
oModule.duration = 0;
oModule.level = 0;
oModule.objectives = "<ul><li></li><li></li></ul>";
oModule.benefit = "";
oModule.addOutline("<b>Orientation</b><br>");
oModule.addExpert();
oModule.addCategory();
oModule.audience = "";
oModule.region = "";
arModules[arModules.length] = oModule;*/





var oModule = new ClsModule();
oModule.code = "PV01";
oModule.title = "An Introduction to Pharmacovigilance (PV)";
oModule.description = "Pharmacovigilance, the monitoring of drug safety, is becoming more important as the number of drugs on the market, drug usage, and number of recalls all increase. This module provides an introduction to the fundamental elements of pre- and post-marketing pharmacovigilance. The global harmonisation of pharmacovigilance data is also highlighted.";
oModule.status = STATUS_LIVE;
oModule.duration = 3;
oModule.level = 0;
oModule.objectives = "<ul><li>Recognise pharmacovigilance as an essential tool for drug safety and monitoring.</li><li>Explain the role of pharmacovigilance in pre-marketing drug development.</li><li>Explain the role of pharmacovigilance in post-marketing surveillance.</li><li>Describe the processes involved in the reporting and monitoring of adverse events in clinical and post-marketing pharmacovigilance.</li><li>Describe the principles of risk analysis and management.</li><li>Identify the need for the global integration of pharmacovigilance data.</li></ul>";
oModule.benefit = "This is an important module for a wide range of staff in the pharmaceutical industry, including those involved in product development, clinical research, regulatory affairs and compliance, medical affairs, and marketing. Healthcare professionals will also find it useful. Specialists in medical informatics and data analysis will wish to familiarise themselves with its contents.";
oModule.addOutline("<b>Orientation</b><br>Designed as an introduction to using the Zenosis modules, this session guides you through the different functions of the module interface - such as how to navigate and interact with the course material. Also provided are five short tips on how to get the most from your e-learning experience.");
oModule.addOutline("<b>Pharmacovigilance: what and why</b><br>The rationale for pharmacovigilance is explained with the aid of historical examples of the consequences of adverse drug reactions. Considerations affecting the balance between benefit and risk of medicinal products are set out. ");
oModule.addOutline("<b>Monitoring and reporting</b><br>Requirements for safety surveillance and reporting are outlined. The different types of adverse events are specified, and sources of safety data are described. Processes for detecting and assessing safety signals are discussed.");
oModule.addOutline("<b>Pre-marketing pharmacovigilance</b><br>Responsibilities for recording, reporting and analysing safety data from clinical trials are described. Factors influencing review of safety data in applications for regulatory approval are set out.");
oModule.addOutline("<b>Post-marketing pharmacovigilance</b><br>Requirements for post-marketing safety monitoring and reporting, including Periodic Safety Update Reports, are described. Types of post-marketing safety studies are discussed, as are revisions to labelling.");
oModule.addOutline("<b>Pharmacovigilance risk management</b><br>Current and developing approaches to the management of risk in the context of pharmacovigilance are examined. Measures to reduce risk to patients and minimise adverse consequences to marketing licence holders are described.");
oModule.addOutline("<b>Summary</b><br>Key point summary of topics covered in the module. Ideal for review, a refresher, or consolidation of learning.");
oModule.addOutline("<b>Assessment</b><br>Multiple-choice mastery assessment.");
oModule.addExpert(4);
oModule.addCategory(1);
oModule.addCategory(2);
oModule.addCategory(5);
oModule.audience = "Regulatory, Compliance";
oModule.region = "USA, Europe, Other";
arModules[arModules.length] = oModule;
/*
var oModule = new ClsModule();
oModule.code = "PV02";
oModule.title = "Pharmacovigilance Systems in the EU and USA";
oModule.description = "A companion to the module on Pharmacovigilance (PV), this module describes in detail systems of monitoring and reporting and covers specifics of PV legislation and systems in the EU and USA.  In the USA, pharmacovigilance has become an important component of broader pharmaceutical risk management objectives. Three new draft guidance documents on risk management, when finalised and published, will represent the US Food and Drug Administration's policy on pre-marketing risk assessment, good pharmacovigilance practices, and the development and use of risk minimisation action plans. Also in draft form from the FDA is the Proposed Rule on Safety Reporting Requirements for Human Drug & Biological Products, commonly referred to as 'The Tome', which if adopted will increase the quantity and quality of safety information reported. In the EU the recently implemented Clinical Trials Directive requires safety reporting through the SUSAR database. Additionally, the Eudravigilance guidance points to investigators' and sponsors' responsibilities in case assessment. This module will enable subscribers to stay up-to-date with the significant future developments in this ever-expanding area of pharmaceutical regulatory affairs.";
oModule.status = STATUS_LIVE;
oModule.duration = 5.5;
oModule.level = 3;
oModule.objectives = "Learners will gain a thorough understanding of the systems which must be established and maintained in order to meet modern standards of pharmacovigilance. They will be able to carry out or supervise the monitoring and reporting of adverse events and the management of the relevant data. They will be familiar with relevant regulatory requirements and procedures in the EU and the USA and with the broader international perspective.";
oModule.benefit = "This is an important module for a wide range of staff in the EU and US pharmaceutical industries, including those involved in product development, clinical research, regulatory affairs and compliance, medical affairs, and marketing. Healthcare professionals will also find it useful. Specialists in medical informatics and data analysis will wish to familiarise themselves with its contents.";
oModule.addOutline("Pharmacovigilance - the basics");
oModule.addOutline("Regulatory aspects");
oModule.addOutline("Systems of monitoring and reporting pharmacovigilance");
oModule.addOutline("Pharmacovigilance in the EU");
oModule.addOutline("Pharmacovigilance in the USA");
oModule.addExpert(4);
oModule.addCategory(1);
oModule.addCategory(2);
oModule.addCategory(5);
oModule.audience = "Regulatory";
oModule.region = "US, Europe";
arModules[arModules.length] = oModule;

var oModule = new ClsModule();
oModule.code = "COM01";
oModule.title = "Patents and Market Exclusivity";
oModule.description = "This module aims to provide pharmaceutical staff with a thorough understanding of the basic principles of the time-limited monopoly provided by patents, the rights conferred and the period of market exclusivity given to newly authorised drugs. The procedures for applying for a patent are explained. Issues involved in the defence and the contesting of patents are described and illustrated by case studies. Patents are territorial in nature. This module will keep both the student and experienced practitioner abreast of amendments to national legislation and relevant and significant developments in case law, in addition to the consequences of such changes in practice.";
oModule.status = STATUS_LIVE;
oModule.duration = 6.5;
oModule.level = 1;
oModule.objectives = "<ul><li>Understand the principles of patents and market exclusivity.</li><li>Explain how to conduct research with an awareness of key patent issues.</li><li>Describe how to apply for a patent.</li><li>Discuss the issues involved with the defence and contesting of patents.</li><ul>";
oModule.benefit = "Research staff in all areas of the pharmaceutical industry, and others involved in the development of drugs or medical devices, will find this module an accessible, practically focused, concise account of a field which is vital to the industry but whose details tend to be little known except by legal specialists.";
oModule.addOutline("<b>Overview</b><br>The content and objectives of the module are summarised, and links to relevant legislative instruments and treaties are provided.");
oModule.addOutline("<b>Legislative framework and patent offices</b><br>Major treaties and national legislative instruments governing patents are set out, and links to the websites of patent offices in Europe and the USA are provided.");
oModule.addOutline("<b>Patentable inventions</b><br>The basics of patents in the pharmaceutical and biotechnology industry are set out. The pressures both to contest and to defend patents are described.");
oModule.addOutline("<b>Limitations on the patent right</b><br>The TRIPS agreement and exclusions from patentability are discussed.");
oModule.addOutline("<b>Applying for a patent</b><br>Patent application procedures, and procedures for challenging patents, in Europe and the USA are detailed.");
oModule.addOutline("<b>Exercising patent rights</b><br>The duration of patents, and procedures for extending patent life in Europe and the USA are described. Types of infringement and exceptions to exclusive rights are discussed.");
oModule.addOutline("<b>Testing generic pharmaceuticals before patent expiry</b><br>'Bolar' provisions in the USA and Europe are explained. Paragraph IV certification and the US 'Orange Book' are discussed. ");
oModule.addOutline("<b>Marketing authorisation and exclusivity periods for new drugs</b><br>Provisions for periods of non-patent marketing exclusivity in Europe and the USA are described.");
oModule.addOutline("<b>Case studies </b><br>Examples of the legal contesting and defence of patents are given.");
oModule.addOutline("<b>Assessment</b><br>Multiple-choice mastery assessment.");
oModule.addExpert(9);
oModule.addCategory(6);
oModule.addCategory(7);
oModule.audience = "Regulatory, Manager, Other";
oModule.region = "USA, Europe, Other";
arModules[arModules.length] = oModule;

var oModule = new ClsModule();
oModule.code = "DEV01";
oModule.title = "Development of Solid Drug Products";
oModule.description = "This module deals with regulatory requirements on the chemistry, manufacture and quality control of solid drug products. Module 3 of the Common Technical Document (CTD) deals with quality of the drug substance and product, and this course focuses on the data requirements of that module for solid drug products. The types of solid drug product are described along with processes of their pharmacy. Quality data requirements are then detailed, concentrating on the CTD section on drug product. Finally, requirements for product information / labelling are outlined. This module will track any future modifications to data requirements for the CTD and keep the subscriber informed of the practical implications of such changes.";
oModule.status = STATUS_LIVE;
oModule.duration = 5;
oModule.level = 1;
oModule.objectives = "<ul><li>Understand the regulatory requirements relating to the chemistry, manufacture and quality control of solid drug products.</li><li>Describe the requirements of the CTD, particularly in relation to solid drug products.</li><li>Specify the data requirements of Module 3 of the CTD.</li><li>Outline the requirements for product information and labelling.</li><ul>";
oModule.benefit = "This module provides practical guidance to staff working in formulation development, manufacturing and quality control of solid drug products, or in regulatory affairs and compliance. It will also be of benefit to specialists in data management or documentation.";
oModule.addOutline("<b>Definitions and background</b><br>This session introduces the various types of solid drug products and their methods of administration.");
oModule.addOutline("<b>Manufacture</b><br>This session examines how the various types of solid drug products are made and introduces the learner to Good Manufacturing Practice.");
oModule.addOutline("<b>Control</b><br>This session shows how the quality of the drug substance and drug product is controlled to ensure consistency of the quality of the product.");
oModule.addOutline("<b>The CTD</b><br>This major session describes in detail the CTD framework and the documentation required for the CTD.");
oModule.addOutline("<b>Product Information</b><br>This session describes the Summary of Product Characteristics (SmPC), in particular the pharmaceutical section of the SmPC.");
oModule.addOutline("<b>Assessment</b><br>Multiple-choice mastery assessment.");
oModule.addExpert(8);
oModule.addCategory(3);
oModule.addCategory(7);
oModule.audience = "Regulatory, Compliance, Other";
oModule.region = "USA, Europe, Other";
arModules[arModules.length] = oModule;

var oModule = new ClsModule();
oModule.code = "DEV02";
oModule.title = "Development of Parenteral Drug Products";
oModule.description = "This module deals with regulatory requirements on the chemistry, manufacture and quality control of parenteral drug products and focuses on the data requirements of Module 3 of the Common Technical Document (CTD). The types of parenteral product are described along with processes of their pharmacy. Quality data requirements are then detailed, concentrating on the CTD section on drug product. Case studies and interactive questions complement the main narrative and offer a substantial opportunity to hone skills in this specialist area. The module will be continually updated to take account of the latest developments.";
oModule.status = STATUS_LIVE;
oModule.duration = 6;
oModule.level = 1;
oModule.objectives = "<ul><li>Understand the regulatory requirements relating to the chemistry, manufacture and quality control of parenteral drug products.</li><li>Describe the requirements of the CTD, particularly in relation to parenteral drug products.</li><li>Specify the data requirements of Module 3 of the CTD.</li><li>Outline the requirements for product information and labelling.</li><ul>";oModule.benefit = "This module provides practical guidance to staff working in formulation development, manufacturing and quality control of parenteral drug products, or in regulatory affairs and compliance. It will also be of benefit to specialists in data management or documentation.";
oModule.addOutline("<b>Definitions and background</b><br>This session introduces the various types of parenteral drug products and their methods of administration.");
oModule.addOutline("<b>Excipients</b><br>This session examines requirements for water and other excipients which can be used in the formulation parenteral drug products.");
oModule.addOutline("<b>Manufacture</b><br>This session describes methods of production, sterilisation and fill used during the manufacture of parenteral drug products.");
oModule.addOutline("<b>Control</b><br>This session describes the main test methods used to assure the quality of parenteral drug products.");
oModule.addOutline("<b>The Common Technical Document(CTD)</b><br>This major session describes in detail the CTD framework and the documentation required for the CTD.");
oModule.addOutline("<b>Product Information</b><br>This session describes the Summary of Product Characteristics (SmPC), in particular the pharmaceutical sections of the SmPC.");
oModule.addOutline("<b>Case studies</b><br>This session describes a number of manufacturing and regulatory issues which could occur during the development of a parenteral drug product and how to resolve them.");
oModule.addOutline("<b>Assessment</b><br>Multiple-choice mastery assessment.");
oModule.addExpert(8);
oModule.addCategory(3);
oModule.addCategory(7);
oModule.audience = "Regulatory, Compliance, Other";
oModule.region = "USA, Europe, Other";
arModules[arModules.length] = oModule;

var oModule = new ClsModule();
oModule.code = "PV03";
oModule.title = "Regulatory Aspects of Pharmacovigilance";
oModule.description = "Pharmacovigilance plays a vital role in ensuring drug safety, patient welfare and regulatory compliance. Companies must be able to demonstrate adherence to pre- and post-marketing pharmacovigilance and follow the guidelines set out by the International Conference on Harmonisation (ICH). Effective and efficient reporting procedures should be used when implementing pharmacovigilance practices.";
oModule.status = FUTURE;
oModule.duration = 4;
oModule.level = 2;
oModule.objectives = "<ul><li>describe regulatory requirements for effective pre-and post-marketing pharmacovigilance</li><li> describe the relationship between pharmacovigilance and approval procedures</li><li>recognise the consequences of pharmacovigilance non-compliance</li><li>explain pharmacovigilance reporting procedures</li></ul>";
oModule.benefit = "This module is designed for regulatory affairs professionals, especially new starters, and all those working in the area of pharmacovigilance.";
oModule.addOutline("The need for global pharmacovigilance");
oModule.addOutline("The role of pharmacovigilance in clinical trials");
oModule.addOutline("Types of adverse events");
oModule.addOutline("Approval procedures, including labelling and the Core Company Safety Information (CCSI)");
oModule.addOutline("Post marketing surveillance and reporting");
oModule.addOutline("Pharmacoepidemiologic studies");
oModule.addOutline("Consequences of non-compliance");
oModule.addOutline("Signal generation and analysis");
oModule.addOutline("Reporting, including ESTRI - Electronic Standards for the Transfer of Regulatory Information");
oModule.addExpert(4);
oModule.addCategory(1);
oModule.addCategory(2);
oModule.addCategory(5);
oModule.audience = "Regulatory, Manager, Other";
oModule.region = "US, Europe, Other";
arModules[arModules.length] = oModule;
*/
var oModule = new ClsModule();
oModule.code = "CT01";
oModule.title = "How to Obtain Approval to Conduct Clinical Trials in the EU";
oModule.description = "A sponsor wishing to conduct clinical studies with an investigational drug in the European Union must seek and gain approval before each phase of clinical development. This entails submitting a Clinical Trial Authorisation (CTA) application to the regulatory Competent Authority of each Member State (MS) in which the clinical trial is to be conducted. At the same time, the sponsor must apply for a favourable opinion from the relevant Ethics Committee(s) in each MS. Only when the authorisation and favourable opinion have been obtained can the trial commence.<br><br>This module provides regulatory professionals with knowledge necessary to enable them to complete and submit applications for CTA and for Ethics Committee (EC) favourable opinion to conduct a clinical trial. It also provides information on what to do to maintain approval if the circumstances of the clinical trial change.";
oModule.status = STATUS_LIVE;
oModule.duration = 3;
oModule.level = 2;
oModule.objectives = "<ul><li>Explain what a Clinical Trial Authorisation (CTA) application is, why it is required, and to which bodies it should be submitted</li><li>Explain what an application for an Ethics Committee (EC) Opinion is, why it is required and to which bodies it should be submitted</li><li>Describe the regulatory environment governing CTA applications and access the key regulatory documents</li><li>Summarise the information that should be included in the CTA and EC applications</li><li>Identify the documents required to support compliant applications for a CTA and an EC opinion</li><li>Identify the information required to complete the application forms in the CTA and EC submissions</li><li>Describe the steps that should be taken if a resubmission is required</li><li>Describe the actions required to maintain a CTA, including the procedure that should be followed when amendments are made to the clinical trial protocol</li></ul>";
oModule.benefit = "This module is primarily aimed at professionals within the pharmaceutical and biotechnology industries who are new to the process of applying for approval to conduct clinical trials in the EU. It will benefit regulatory affairs professionals and those involved in clinical research, and project management. Professionals who wish to improve their understanding of the CTA and EC application processes will also find the module useful.";
oModule.addOutline("<b>Orientation</b><BR>Designed as an introduction to using the Zenosis modules, this part guides you through the different functions of the module interface - such as how to navigate and interact with the course material. Also provided are five short tips on how to get the most from your e-learning experience.");
oModule.addOutline("<b>Overview</b><br>The requirements for CTA and EC favourable opinion are introduced, and the scope and learning objectives of the module are specified.");
oModule.addOutline("<b>The European context</b><br>The EU regulatory environment is described, the Clinical Trials Directive is introduced, and the requirements on clinical trials are summarised.");
oModule.addOutline("<b>Applying for approval</b><br>The required contents of the two submissions are summarised, and the main steps in the application processes are set out.");
oModule.addOutline("<b>The CTA application</b><br>The main elements of the CTA application are described, particularly the Investigator's Brochure and the Investigational Medicinal Product Dossier, and the data required are discussed. The timelines of the application process are specified.");
oModule.addOutline("<b>The EC application</b><br>The key components of the EC application are described, particularly the clinical protocol and documents relating to patient recruitment and informed consent. The timelines of the application process are specified.");
oModule.addOutline("<b>Maintaining a CTA</b><br>The procedures necessary to maintain authorisation are described, particularly the submission of amendments and the reporting of adverse reactions.");
oModule.addOutline("<b>Summary</b><br>Key point summary of topics covered in the module. Ideal for review, a refresher, or consolidation of learning.");
oModule.addOutline("<b>Assessment</b><br>Multiple-choice mastery assessment.");
oModule.addExpert(2);
oModule.addCategory(1);
oModule.addCategory(5);
oModule.audience = "Regulatory";
oModule.region = "Europe";
arModules[arModules.length] = oModule;

var oModule = new ClsModule();
oModule.code = "CT03";
oModule.title = "An Introduction to ICH Good Clinical Practice (ICH-GCP)";
oModule.description = "The pharmaceutical industry is undergoing many regulatory changes. Those of us involved in research are directly affected. When carrying out our duties there is a risk of compromising the quality of data we generate and of breaching ethical codes. An understanding of the background and the principles of Good Clinical Practice are critical to ensure ethical research, high quality and credible data.<p>This module describes the key principles and structure of ICH GCP and, by using actual practitioner experience and accounts, provides a broad framework in which to apply the standards of Good Clinical Practice.";
oModule.status = STATUS_LIVE;
oModule.duration = 4;
oModule.level = 0;
oModule.objectives = "<ul><li>Understand the processes involved in establishing international standards and technical requirements for Good Clinical Practice.</li><li>Describe the principles and structure of ICH GCP.</li><li>Apply the main guidelines of  Good Clinical Practice in the workplace.</li><li>Explain the key responsibilities of the Sponsor, Investigator, Monitor and the Study Team in conducting a successful clinical trial.</li><li>Understand the use of key documentation used in clinical trials.</li><li>Demonstrate an understanding of the informed consent process in clinical trials.</li></ul>";
oModule.benefit = "This course provides essential learning for clinical research associates, project managers and other employees of companies sponsoring clinical research, as well as all healthcare professionals involved in conducting clinical trials. Anyone who needs to develop an understanding of the importance of Good Clinical Practice and its application should take this course. ";
oModule.addOutline("<b>Orientation</b><br>Designed as an introduction to using the Zenosis modules, this session guides you through the different functions of the module interface - such as how to navigate and interact with the course material. Also provided are five short tips on how to get the most from your e-learning experience.");
oModule.addOutline("<b>Harmonisation</b><br>The topics covered in this session map the development of ICH and the processes involved in establishing international standards and the technical requirements to ensure the safety, quality and efficacy of new medicines.");
oModule.addOutline("<b>ICH GCP Guidelines</b><br>The topics covered in this session describe the principles and structure of ICH GCP and provide a broad context in which to apply the standards of good clinical practice.");
oModule.addOutline("<b>Teamwork</b><br>This session examines the roles of the sponsor, investigator and monitor and the communication and interaction necessary to fulfil these obligations and conduct a successful trial.");
oModule.addOutline("<b>Documentation</b><br>This session connects these key documents with the responsibilities of the investigator, sponsor, monitor and support team.");
oModule.addOutline("<b>Investigator responsibilities</b><br>This session covers the main responsibilities of investigators for the conduct of the clinical trial and explains how to ensure the accuracy, completeness, legibility and timeliness of data generated during the study.");
oModule.addOutline("<b>Informed consent</b><br>This session focuses on the main requirements necessary to support an effective and efficient informed consent process.");
oModule.addOutline("<b>Monitor responsibilities</b><br>This session explores the responsibilities of monitors and provides insight into their key challenges.");
oModule.addOutline("<b>Assessment</b><br>Multiple-choice mastery assessment.");
oModule.addExpert(3);
oModule.addCategory(1);
oModule.addCategory(2);
oModule.audience = "Regulatory, Compliance";
oModule.region = "USA, Europe, Other";
arModules[arModules.length] = oModule;

var oModule = new ClsModule();
oModule.code = "CT04";
oModule.title = "An Introduction to Clinical Trial Preparation and Design";
oModule.description = "Worldwide expenditure on R&D by the pharmaceutical industry is continually increasing. Most of the financial investment in the production of a new drug is allocated to clinical trials.<br><br>Given the financial risk involved, it is crucially important that clinical trials be designed and set up efficiently to obtain adequate and accurate data in compliance with regulatory requirements.<br><br>This module sets out the fundamentals of effective preparation and design of clinical trials.  It establishes the medical-scientific and regulatory context, describes procedures to be followed, and explains the rationale for choosing design parameters.";
oModule.status = STATUS_LIVE;
oModule.duration = 4; 
oModule.level = 0;
oModule.objectives = "<ul><li>Outline the role of clinical trial design in clinical research.</li><li>Identify the relevant legal documents and guidelines relating to clinical trial design.</li><li>Recognise the essential statistical components for clinical trial design and how these affect design choice.</li><li>Define the general principles and concepts for trial design, and describe the implications of design choice on regulatory acceptance.</li><li>Identify the strategies to improve data capture and management.</li><li>Describe how electronic data capture can improve clinical trial development.</li></ul>";
oModule.benefit = "This module is intended for all those involved in the preparation, design, conduct or analysis of clinical trials.  It will be useful to new entrants to the field or as a refresher for staff, including clinical research associates and data managers, in the clinical/medical departments of pharmaceutical or biotechnology companies or in contract research organisations.  It will also be of interest to clinical investigators, study coordinators, and other healthcare staff working on clinical trials.";
oModule.addOutline("<b>Orientation</b><br>Designed as an introduction to using the Zenosis modules, this session guides you through the different functions of the module interface - such as how to navigate and interact with the course material. Also provided are five short tips on how to get the most from your e-learning experience.");
oModule.addOutline("<b>Overview</b><br>This session briefly describes the relevant legal documents and guidelines relating to clinical trial design.");
oModule.addOutline("<b>Clinical trials in drug development</b><br>The crucial role of clinical trials in the drug development cycle is examined. Regulatory requirements and financial pressures, and their interaction with trial design, are discussed.");
oModule.addOutline("<b>Protocol design</b><br>This session provides an overview of clinical trial protocols. Opportunities to improve a clinical trial protocol for regulatory approval are also discussed.");
oModule.addOutline("<b>Clinical trial preparation</b><br>This session provides an overview of the role of the sponsor in supporting and improving quality in the conduct of clinical trials.");
oModule.addOutline("<b>Endpoints</b><br>This session focuses on clinical trial endpoints. The purpose of endpoints and the types are discussed in this part.");
oModule.addOutline("<b>Statistical elements</b><br>This session covers the role of statistics in clinical trial design and analysis, as acknowledged in the International Conference on Harmonisation (ICH) guideline for Good Clinical Practice (GCP).");
oModule.addOutline("<b>Study design</b><br>This session provides an overview of the main types of study design.");
oModule.addOutline("<b>Data capture and management</b><br>This session describes the purpose of data capture and explores efficiencies in data management as part of the evolving regulatory landscape.");
oModule.addOutline("<b>Summary</b><br>Key point summary for all topics covered in this module. Ideal for review, a refresher or consolidation of learning points.");
oModule.addOutline("<b>Assessment</b><br>Multiple-choice mastery assessment.");
oModule.addExpert(10);
oModule.addCategory(1);
oModule.audience = "Regulatory, Manager, Other";
oModule.region = "USA, Europe, Other";
arModules[arModules.length] = oModule;

var oModule = new ClsModule();
oModule.code = "CT05";
oModule.title = "An Introduction to Clinical Trials in India";
oModule.description = "India has been identified as an increasingly attractive country for conducting clinical trials and providing data management services. With its large patient population, well-trained investigators and considerably lower trial costs than in developed nations, India has gained wide recognition as a country capable of offering opportunities for conducting clinical trials.<p>India's rapidly evolving regulatory environment based on the fundamentals outlined by the International Conference on Harmonisation (ICH) guideline for Good Clinical Practice (GCP) further enhances India's reputation as a suitable location to conduct global clinical trials.<p>This module details the aspects of culture, custom and practice in India which investigators must understand in order to consider clinical trials in the country.";
oModule.status = STATUS_LIVE;
oModule.duration = 3;
oModule.level = 0;
oModule.objectives = "<ul><li>Outline the factors that make India suitable for conducting clinical trials.</li><li>Recognise the global pharmaceutical sponsors' concerns about conducting clinical trials in India.</li><li>Review the opportunities and challenges for conducting clinical trials in India.</li><li>Evaluate cost-effectiveness provided by clinical trials in India.</li><li>Discuss the regulatory requirements which must be complied with when conducting clinical trials in India in order to license medicinal products in the EU and USA.</li></ul>";
oModule.benefit = "This module is primarily aimed at those individuals involved in the clinical research and development area. Individuals such as development directors and project managers looking to outsource clinical trials in India will also benefit from this module. Other individuals include clinical trial development planners and strategic planners, CRAs within the clinical industry exploring new studies of a new drug for trial in India, clinical study monitors, medical writers, sponsors, clinical investigators, regulatory authorities and Ethics Committees.";
oModule.addOutline("<b>Orientation</b><br>Designed as an introduction to using the Zenosis modules, this session guides you through the different functions of the module interface - such as how to navigate and interact with the course material. Also provided are five short tips on how to get the most from your e-learning experience.");
oModule.addOutline("<b>Overview</b><br>This session briefly describes the legislative instruments that apply to the conduct of clinical trials in India.");
oModule.addOutline("<b>Background to India</b><br>This session outlines the Indian environment and the factors that make India suitable for conducting clinical trials.");
oModule.addOutline("<b>Indian clinical development sector</b><br>This session provides a review of the opportunities for conducting clinical trials in India. At the end of this session, you will be able to evaluate factors to be considered before conducting clinical trials in India.");
oModule.addOutline("<b>Regulatory landscape</b><br>This session discusses the framework of regulations that must be complied with to conduct clinical trials in India of medicinal products intended for US and EU markets.");
oModule.addOutline("<b>Potential concerns</b><br>This session examines the concerns of global companies about conducting clinical trials in India.");
oModule.addOutline("<b>Addressing concerns</b><br>This session examines the strategies India has adopted to overcome global pharmaceutical companies' concerns.");
oModule.addOutline("<b>Case study: CROs</b><br>This session provides you with the opportunity to put your knowledge of how to conduct clinical trials in India to the test. You will be addressing important points to consider when selecting and working with a Contract Research Organisation (CRO). How can you ensure potential problems are adequately managed?");
oModule.addOutline("<b>Summary</b><br>Key point summary for all topics covered in this module. Ideal for review, a refresher or consolidation of learning points.");
oModule.addOutline("<b>Assessment</b><br>Multiple-choice mastery assessment.");
oModule.addExpert(11);
oModule.addCategory(1);
oModule.addCategory(5);
oModule.audience = "Regulatory, Manager";
oModule.region = "Other";
arModules[arModules.length] = oModule;

var oModule = new ClsModule();
oModule.code = "CT06";
oModule.title = "Clinical Trial Monitoring: Site Evaluation and Set-up";
oModule.description = "The purpose of site evaluation and set-up is to ensure that the site has access to the required patient population, has appropriately qualified staff, adequate time and facilities to conduct the study and to ensure the site is fully prepared for the conduct of the clinical trial.<br/><br/>This module provides an understanding of the training requirements for clinical research associates (CRAs), including familiarisation with study documentation. The procedures necessary prior to initiation of an investigational site, particularly the site qualification visit, are described in detail. The responsibilities and procedures associated with preparing for and conducting initiation visits are also covered in detail.";
oModule.status = STATUS_LIVE;
oModule.duration = 4;
oModule.level = LEVEL_I;
oModule.objectives = "<ul><li>Describe the evaluation and qualification process at an investigational site.</li><li>Identify the study documentation required prior to commencing work on a clinical trial.</li><li>Describe what is required of a study site to conduct a clinical trial successfully.</li><li>Outline the procedures to be conducted prior to the initiation of a study site.</li><li>Describe the measures taken during site evaluation, set-up and initiation to ensure that the conduct of clinical trials complies with the protocol.</li><li>Describe the initiation process at an investigational site.</li></ul>";
oModule.benefit = "This module is primarily aimed at those individuals involved in the clinical research and development area, in particular those involved in the monitoring of clinical trials at the investigational site, and those who require an understanding of what this entails. Individuals such as CRAs/monitors working in the field who are looking for additional training and professional development will benefit from this module. Other individuals include clinical trial administrators and study coordinators who require more training in order to enter the wider CRA employment market.";
oModule.addOutline("<b>Orientation</b><br>Designed as an introduction to using the Zenosis modules, this session guides you through the different functions of the module interface - such as how to navigate and interact with the course material. Also provided are five short tips on how to get the most from your e-learning experience.");
oModule.addOutline("<b>Overview</b><br>This session briefly describes the legislative guidelines that apply to the conduct of clinical trials.");
oModule.addOutline("<b>CRA training</b><br>This session outlines the training requirements for site monitoring according to International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines. The study documentation with which a CRA should be familiar prior to commencing work on a clinical trial is also discussed.");
oModule.addOutline("<b>Site qualification visit</b><br>This session outlines the preparation, conduct and follow-up of a site qualification visit.");
oModule.addOutline("<b>Groundwork</b><br>This short session provides an overview of the site-related activities which will occur between the site qualification and initiation visit. Although a CRA might not be actively involved, groundwork activities are integral to successful site initiation.");
oModule.addOutline("<b>Initiation visit</b><br>This session outlines the preparation, conduct and follow-up of an initiation visit.");
oModule.addOutline("<b>Summary</b><br>Key point summary for all topics covered in this module. Ideal for review, a refresher or consolidation of learning points.");
oModule.addOutline("<b>Assessment</b><br>Multiple-choice mastery assessment.");
oModule.addExpert(16);
oModule.addCategory(1);
oModule.audience = "Compliance, Manager, Other";
oModule.region = "USA, Europe, Other";
arModules[arModules.length] = oModule;

var oModule = new ClsModule();
oModule.code = "CT07";
oModule.title = "Introduction to Clinical Trials and Drug Development";
oModule.description = "This module provides an understanding of how clinical trials fit into the drug development process. It outlines the key historical events leading to the development of controlled clinical trials. It specifies the purpose of trials, outlines their features, and identifies codes and regulations that apply to them. Finally, it describes the environment of cost control in which the modern pharmaceutical industry operates.";
oModule.status = STATUS_LIVE;
oModule.duration = 2;
oModule.level = LEVEL_F;
oModule.objectives = "<ul><li>Summarise the key historical events leading to the development of controlled clinical trials; describe the purpose of a clinical trial.</li><li>Outline the legislative and ethical framework.</li><li>Describe how clinical trials fit into the drug development process.</li><li>Outline the environment of cost control in which the modern pharmaceutical industry operates.</li></ul>";
oModule.benefit = "This module is primarily aimed at those new to the clinical research and development area: in particular those who require an understanding of why clinical trials are necessary, how they are performed, and a grounding in the wider ethical and regulatory landscape in which they are carried out. Those new to the pharmaceutical industry, such as starting clinical research associates and juniors in regulatory affairs will benefit from this module. Others, including those from contract research organisations, hospital staff and IT personnel involved in clinical trials and data management, will benefit from the introductory nature of this module.";
oModule.addOutline("<b>Orientation</b><br>Designed as an introduction to using the Zenosis modules, this part guides you through the different functions of the module interface - such as how to navigate and interact with the course material. This part also provides five short tips on how to get the most from your e-learning experience.");
oModule.addOutline("<b>Overview</b><br>The context of the pharmaceutical industry and modern medicine is established. The module's four perspectives on clinical trials are set out.");
oModule.addOutline("<b>History</b><br>Factors that gave rise to the modern framework of regulation of clinical trials are traced. ");
oModule.addOutline("<b>Codes and regulations</b><br>The principal elements of regulation of clinical trials are set out. The regulatory frameworks of the USA, Europe and Japan are outlined. International harmonisation of requirements through the work of ICH is discussed, with particular reference to Good Clinical Practice. ");
oModule.addOutline("<b>Drug development</b><br>The long and financially risky process of developing a drug is described. The various stages of discovery, nonclinical and clinical development are detailed.");
oModule.addOutline("<b>Global market </b><br>Commercial considerations in drug development are described. Issues such as financial risk, pharmacoeconomics, patent life and generics are discussed. ");
oModule.addOutline("<b>Assessment</b><br>Multiple-choice mastery assessment.");
oModule.addExpert(15);
oModule.addCategory(1);
oModule.audience = "Regulatory, Compliance, Other";
oModule.region = "USA, Europe, Other";
arModules[arModules.length] = oModule;

var oModule = new ClsModule();
oModule.code = "CT08";
oModule.title = "Clinical Trial Monitoring: Study Monitoring, Documentation and Closure";
oModule.description = "Once a trial is initiated, the crucial role of the clinical research associate (CRA) is to monitor the conduct of the trial and the integrity of the data recorded.<br><br>This module introduces areas such as monitoring of case report forms (CRFs), source document verification and the review and maintenance of essential documents. The responsibilities and procedures associated with monitoring processes and close-out visits are also explained.";
oModule.status = STATUS_LIVE;
oModule.duration = 4;
oModule.level = LEVEL_I;
oModule.objectives = "<ul><li>Outline the monitoring activities conducted on a site visit.</li><li>Identify the requirements for accurate and consistent CRF completion by site staff.</li><li>Define the CRA's responsibilities for the monitoring and review of CRFs.</li><li>Define source documents and the procedures for source document verification.</li><li>Identify the essential documents which must be available prior to the commencement of a clinical trial at each investigational site, during the conduct of a clinical trial, and after completion or termination of a clinical trial to comply with ICH Good Clinical Practice (GCP) guidelines.</li><li>Describe the procedures to be conducted to close a trial at each investigational site, when the requirements of the protocol have been fulfilled, or if continuation of the trial is considered inappropriate.</li><li>Explain the importance of sponsor site audits.</li><li>Summarise the role of the monitor in preparation for a site audit.</li><li>Identify the responsibilities of the CRA in identifying and reporting scientific misconduct.</li></ul>";
oModule.benefit = "This module is primarily aimed at those individuals involved in the clinical research and development area, in particular those involved in the monitoring of clinical trials at the investigational site, and those who require an understanding of what this entails. Individuals such as CRAs/monitors working in the field who are looking for additional training and professional development will benefit from this module. Other individuals include clinical trial administrators and study coordinators who require more training in order to enter the wider CRA employment market.";
oModule.addOutline("<b>Orientation</b><br>Designed as an introduction to using the Zenosis modules, this session guides you through the different functions of the module interface - such as how to navigate and interact with the course material. Also provided are five short tips on how to get the most from your e-learning experience.");
oModule.addOutline("<b>Overview</b><br>This session briefly describes the legislative guidelines used to conduct clinical trials.");
oModule.addOutline("<b>Monitoring visit</b><br>This session outlines the preparation, conduct and follow-up of a routine monitoring visit.");
oModule.addOutline("<b>CRF review</b><br>Case Report Forms are crucial in conducting a successful clinical trial. This session discusses the monitoring and review of CRFs.");
oModule.addOutline("<b>Source document verification</b><br>Inadequate understanding of the process involved in source document verification results in the procedure being ineffective. This session explains the importance of source document verification in clinical trials.");
oModule.addOutline("<b>Essential documents: Collection and review</b><br>The ICH GCP guideline identifies a minimum list of essential documents that are required throughout a trial, including specific details of where each document should be filed during the study, and their purpose. This session summarises these documents. The contents of the Trial Master File and Investigator Site File are also described.");
oModule.addOutline("<b>Close-out visit</b><br>This session outlines the preparation, conduct and follow-up of a close-out visit. ");
oModule.addOutline("<b>Sponsor site audits</b><br>This session will focus on sponsor site audits. The purpose of sponsor audits will be described, as well as the role of the CRA and common audit findings.");
oModule.addOutline("<b>Fraud and scientific misconduct</b><br>CRAs are sometimes faced with serious situations, namely errors, misconduct and fraud. This session will focus primarily on the CRA's role in these unfortunate events.");
oModule.addOutline("<b>Summary</b><br>Key point summary for all topics covered in this module. Ideal for review, a refresher or consolidation of learning points.");
oModule.addOutline("<b>Assessment</b><br>Multiple-choice mastery assessment.");
oModule.addExpert(16);
oModule.addCategory(1);
oModule.audience = "Compliance, Manager, Other";
oModule.region = "USA, Europe";
arModules[arModules.length] = oModule;


var oModule = new ClsModule();
oModule.code = "CT09";
oModule.title = "Preparing for a GCP Audit or Inspection.";
oModule.description = "Clinical trial sites of sponsors and investigators are subject to rigorous inspection by regulatory agencies to ensure compliance with Good Clinical Practice (GCP). Auditing assures the agency (and the sponsor) that good standards are being maintained and that the sites are fit for undertaking clinical research studies.<br><br>Preparing adequately to cooperate with auditors/inspectors requires an understanding of their agendas and goals. Understanding why specific documentation, processes and functions are checked and what the auditor/inspector is looking for will substantially enhance internal QA procedures. <br><br>This module explores the phases preceding a GCP audit/inspection. It gives an overview of what is meant by audits/inspections and demystifies the whole process by breaking it down to its original components.  The differences between audits and inspections are explained in so far as they affect the stages leading up to the procedures themselves. European and US aspects are examined in the context of audit/inspection of the sponsor's and of the investigator's site.";
oModule.status = STATUS_LIVE;
oModule.duration = 2;
oModule.level = 2;
oModule.objectives = "<ul><li>Understand the reasons for audits and inspections.</li><li>Explain what needs to be done prior to an audit/inspection of a sponsor's site.</li><li>Explain what needs to be done prior to an audit/inspection of an investigator's site.</li><li>Understand the audit/inspection of external suppliers.</li></ul>";
oModule.benefit = "CRAs/monitors, investigators, clinical research staff, personnel of QA departments of sponsor's, investigator's and CRO's sites will all benefit from taking this module. However, it is not intended for those responsible for carrying out audits or inspections.<br><br>In principle this module can be rolled out prior to an audit/inspection as a general preparation for the event itself, though it is not meant to replace an internal training programme devised for a specific audit/inspection.";
oModule.addOutline("<b>Introduction</b><br>This session explains the reasons for having audits/inspections, introduces the people involved in them and clarifies the general terminology and main differences between the US and European systems.");
oModule.addOutline("<b>The investigator's audit/inspection</b><br>This session outlines which functions, processes and documentation are audited/inspected at the investigator's site and what personnel at the site need to be aware of in order to prepare.");
oModule.addOutline("<b>The sponsor's audit/inspection</b><br>This session outlines which functions, processes and documentation are audited/inspected at the sponsor's site and what personnel at the site need to be aware of in order to prepare.");
oModule.addOutline("<b>Audit/inspection of external suppliers</b><br>This session focuses on the arrangements that need to be in place between sponsors and external suppliers to ensure that causes for concern affecting audits/inspections are properly managed.");
oModule.addOutline("<b>Tools and case studies</b><br>Case studies help to review newly acquired knowledge and set it in a realistic context. An audit/inspection checklist is also provided as reference material.");
oModule.addOutline("<b>Assessment</b><br>Multiple-choice mastery assessment.");
oModule.addExpert(17);
oModule.addCategory(1);
oModule.audience = "Compliance, Manager, Other";
oModule.region = " Europe, USA";
arModules[arModules.length] = oModule;

var oModule = new ClsModule();
oModule.code = "CT10";
oModule.title = "The IND: How to Gain Approval for Clinical Trials in the USA";
oModule.description = "The Investigational New Drug (IND) application is a submission to the Food and Drug Administration (FDA) through which the sponsor seeks approval to conduct clinical studies with an investigational drug. <br/><br/>The IND application is the crucial stepping stone from non-clinical to clinical testing. The IND must contain information on a number of areas including animal pharmacology, drug distribution, toxicology, manufacturing, and the clinical protocol.<br/><br/>This module will provide regulatory professionals with the background and necessary detail needed to complete and submit an IND application for FDA approval.";
oModule.status = STATUS_LIVE;
oModule.duration = 3;
oModule.level = 2;
oModule.objectives = "<ul><li>Describe what an IND is, and why it is needed.</li><li>Access the key regulatory documents surrounding INDs.</li><li>Describe the content and format of an IND application.</li><li>Describe the IND review and approval process.</li><li>Describe the IND reporting requirements, and the types of amendments that can be made to an IND.</li></ul>";
oModule.benefit = "This module is primarily aimed at Regulatory professionals who are new to the IND application process. Professionals in clinical research, data processing, project management and marketing, and those whose role involves interaction with the FDA will also benefit from this module.<br><br>Individuals, within the pharmaceutical and biotechnology industries, who desire a greater understanding of writing regulatory submissions for the approval of products, will also find this module valuable.";
oModule.addOutline("<b>Orientation</b><br>Designed as an introduction to using the Zenosis modules, this session guides you through the different functions of the module interface - such as how to navigate and interact with the content material. Also provided are five short tips on how to get the most from your e-learning experience.");
oModule.addOutline("<b>Regulatory overview</b><br>This session briefly describes the legislative guidelines that apply to obtaining FDA approval to conduct clinical trials in the USA.");
oModule.addOutline("<b>An introduction to Investigational New Drug Applications</b><br>This session provides a brief overview of the IND and of the submission process.");
oModule.addOutline("<b>IND content and format requirements</b><br>Explore the specific format and content requirements of an IND application as specified by the Center for Drug Evaluation and Research (CDER).");
oModule.addOutline("<b>The IND review and approval process</b><br>This session discusses the FDA review principles for IND applications, with a view to improving your application.");
oModule.addOutline("<b>Maintenance of an IND </b><br>This session outlines the different types of IND amendments, when they are required, and the regulations that govern them.");
oModule.addOutline("<b>Summary</b><br>Key point summary for all topics covered in this module. Ideal for review, a refresher or a consolidation of learning points.");
oModule.addOutline("<b>Assessment</b><br>Multiple-choice mastery assessment.");
oModule.addExpert(19);
oModule.addCategory(1);//
oModule.addCategory(5);//
oModule.audience = "Regulatory, Compliance, Manager, Other";
oModule.region = "USA";
arModules[arModules.length] = oModule;

var oModule = new ClsModule();
oModule.code = "SC01";
oModule.title = "Pharmacokinetics and Pharmacodynamics in Drug Registration";
oModule.description = "Pharmacokinetic and pharmacodynamic (PK/PD) studies play a vital role in drug development. Regulatory authorities are placing greater emphasis on the role of PK/PD in drug registration. This module enables the learner to understand the role of PK/PD data in establishing the safety profile of a new or generic product.";
oModule.status = STATUS_LIVE;
oModule.duration = 3.5;
oModule.level = 2;
oModule.objectives = "<ul><li>Explain the role of PK/PD studies in modern drug development and registration.</li><li>Describe the use of PK/PD data from nonclinical and clinical studies.</li><li>Recognise the role of PK parameters in special population studies.</li><li>Identify the processes used to obtain PK/PD data from nonclinical and clinical studies.</li><li>Describe the PK/PD factors underpinning the concepts of bioavailability and bioequivalence.</li></ul>";
oModule.benefit = "Pharmacologists, nonclinical and clinical researchers, and others involved in drug development will find this module an accessible, concise account of the relevance of PK & PD in the registration of drugs for human use. A basic knowledge of the terminology of PK and PD is assumed.";
oModule.addOutline("<b>Orientation</b><br>Designed as an introduction to using the Zenosis modules, this session guides you through the different functions of the module interface - such as how to navigate and interact with the course material. Also provided are five short tips on how to get the most from your e-learning experience.");
oModule.addOutline("<b>PK/PD role and relevance</b><br>The role and relevance of PK and PD in the registration of new and generic drugs is described. The emerging trend towards formal standardisation of PK studies is discussed.");
oModule.addOutline("<b>PK/PD studies in drug development</b><br>The role of PK/PD studies in nonclinical and clinical studies is explained. Study designs are discussed. Bioavailability, ADME and toxicokinetic studies are described. A variety of clinical studies are outlined in the context of PK.");
oModule.addOutline("<b>Drug administration routes</b><br>Time-concentration curves for various routes of administration are compared. Prediction of the best route, on the basis of PK data, is discussed.");
oModule.addOutline("<b>PD for drug registration</b><br>The distinction between PD effects and clinical outcomes is explained. Examples of dose-response curves and their interpretations are given. The importance of dose-response relationships in clinical trials and drug registration is discussed.");
oModule.addOutline("<b>Sampling practice and outcomes</b><br>Common PK variables derived from sampling are described. Good sampling practice is discussed.");
oModule.addOutline("<b>Data analysis </b><br>Compartmental and non-compartmental analysis are compared. Uses of AUC and volume of distribution are described.");
oModule.addOutline("<b>Special populations</b><br>Requirements for studies in populations such as those with liver or kidney dysfunction are described.");
oModule.addOutline("<b>Generics and bioequivalence</b><br>The principles and practice of bioequivalence studies for the registration of generic products are described.");
oModule.addOutline("<b>Summary</b><br>Key point summary of topics covered in the module. Ideal for review, a refresher, or consolidation of learning.");
oModule.addOutline("<b>Assessment</b><br>Multiple-choice mastery assessment.");
oModule.addExpert(13);
oModule.addCategory(0);
oModule.addCategory(1);
oModule.audience = "Regulatory, Manager, Other";
oModule.region = "USA, Europe, Other";
arModules[arModules.length] = oModule;



var oModule = new ClsModule();
oModule.code = "GXP01";
oModule.title = "An Introduction to Good Manufacturing Practice (GMP) for Drug Products";
oModule.description = "GMP is that part of Quality Assurance which ensures that pharmaceutical products are consistently manufactured to the quality standards appropriate to their intended use and as required by a marketing authorisation or product specification. Manufacturers' compliance with GMP legislation is a requirement of approval of regulatory submissions. Manufacturers are subject to inspection and audit by regulatory authorities. Non-compliance with GMP requirements can have significant commercial consequences for a pharmaceutical company. In an area that is subject to stringent enforcement of the regulatory requirements, this module provides continually updated guidance on GMP requirements.";
oModule.status = STATUS_LIVE;
oModule.duration = 6;
oModule.level = 0;
oModule.objectives = "<ul><li>Identify the principal issues that need to be addressed to comply with GMP regulations and guidelines.</li><li>Describe deficiencies in GMP that may be identified by regulatory inspectors, and consequences that may arise if they are not rectified.</li><li>Apply principles of GMP in your own manufacturing circumstances.</li></ul>";
oModule.benefit = "All staff involved in manufacturing and quality control in pharmaceutical companies or their suppliers need to be up to date with current GMP requirements. They will find this course an invaluable guide and reference source.";
oModule.addOutline("<b>Why GMP?</b><br>This session describes the origins of GMP and the consequences of non-compliance.");
oModule.addOutline("<b>Regulatory framework</b><br>This session describes the legislative instruments and guidance documents which define codes for GMP compliance in the EU, USA and other countries.");
oModule.addOutline("<b>Quality management</b><br>This session describes the main elements of a quality assurance system which a company would need to establish in order to achieve GMP compliance and describes how procedures for release of product duffer between the EU and USA.");
oModule.addOutline("<b>Personnel</b><br>This session describes the responsibilities of personnel working in a GMP regulated environment, particularly in relation to training, clothing, protective equipment and hygiene.");
oModule.addOutline("<b>Premises</b><br>This session describes how building design, layout, organisation and environmental control is an important consideration in a GMP environment.");
oModule.addOutline("<b>Equipment</b><br>This session emphasises the importance of using clean, calibrated, well maintained and validated equipment in a GMP environment.");
oModule.addOutline("<b>Documentation principles</b><br>This session sets out the requirements for record keeping, with particular reference to creation, amendment, authorisation, retention and retrieval.");
oModule.addOutline("<b>Document types</b><br>This session specifies the contents of a range of document types. It also provides examples of good and bad practice in the layout of records.");
oModule.addOutline("<b>Production principles</b><br>This session outlines the general principles that apply to all production processes, especially validation, change-control and measures to prevent contamination and cross-contamination.");
oModule.addOutline("<b>Materials and operations</b><br>This session describes checks and controls which should be applied to starting and packaging materials, process and packaging operations and handling rejected or returned materials and products.");
oModule.addOutline("<b>Quality Control</b><br>This session identifies the responsibilities of the Quality Control department with particular reference to documentation, sampling and stability testing.");
oModule.addOutline("<b>Contract manufacture and analysis</b><br>Pharmaceutical manufacturers may contract out analysis or production work. This session describes the responsibilities of the contract giver and acceptor and outlines the contents of a contract.");
oModule.addOutline("<b>Complaints and product recall</b><br>This session describes how a manufacturer should handle product complaints and manage product recall operations.");
oModule.addOutline("<b>Self-inspection</b><br>In this session the main characteristics of a self-inspection programme are described and issues concerning the disclosure of self-inspection reports to regulatory inspectors are discussed.");
oModule.addOutline("<b>Summary</b><br>Key point summary for all topics covered in the module. Ideal for a refresher or consolidation of learning points.");
oModule.addOutline("<b>Assessment</b><br>Multiple-choice mastery assessment.");
oModule.addExpert(14);
oModule.addCategory(3);
oModule.addCategory(4);
oModule.audience = "Compliance, Manager";
oModule.region = "USA, Europe, Other";
arModules[arModules.length] = oModule;

var oModule = new ClsModule();
oModule.code = "";
oModule.title = "Essentials of Regulatory Affairs in Japan";
oModule.description = "For companies seeking to gain product approval in the second largest pharmaceutical market in the world, it is necessary not only to navigate regulatory requirements but also to be aware of the differences between the regulatory standards and practice, where the latter typically meets higher standards. Following the relatively recent changes to the Pharmaceutical Affairs Law, there is a prime opportunity for many companies and CROs wishing to expand into this market. The regulatory affairs outlook in Japan will need to adapt and change further to manage this interest, and this module will monitor any developments and provide an excellent source of fundamental information in this market. This module provides the learner with a detailed view of the Japanese market, key players, Japanese regulations, strategic considerations for drug development in Japan, clinical trial notification, acceptance of foreign data, CTD requirements for licensing approvals, and post-marketing surveillance and pharmacovigilance. The module also touches on pricing and reimbursement issues as well as trends and future expectations.";
oModule.status = STATUS_FUTURE;
oModule.duration = 6;
oModule.level = 1;
oModule.objectives = "The learner will gain an understanding of key issues affecting drug development, marketing, and regulatory affairs and compliance in Japan.";
oModule.benefit = "All staff concerned with drug development, marketing, or regulatory affairs and compliance and who seek a thorough grounding in the Japanese pharmaceutical landscape will find this module invaluable.";
oModule.addOutline("History and background of regulatory affairs in Japan");
oModule.addOutline("Key players in Japanese regulatory affairs");
oModule.addOutline("Japanese regulations");
oModule.addOutline("Regulatory standards for drug development");
oModule.addOutline("Strategic considerations for new drug development");
oModule.addOutline("Preclinical development");
oModule.addOutline("Clinical trials");
oModule.addOutline("Chemistry, manufacturing and controls");
oModule.addOutline("The application");
oModule.addOutline("Licensing approvals and procedures");
oModule.addOutline("Post-marketing requirements and licence maintenance");
oModule.addOutline("Pricing and reimbursement");
oModule.addOutline("Commercial issues");
oModule.addOutline("Approval of foreign-manufactured drugs");
oModule.addOutline("Japanese relations with the EU and USA");
oModule.addOutline("Trends and future expectations");
//oModule.addExpert();
oModule.addCategory();
oModule.audience = "";
oModule.region = "";
arModules[arModules.length] = oModule;

var oModule = new ClsModule();
oModule.code = "";
oModule.title = "Registration of Vaccines in the EU & USA";
oModule.description = "This module introduces the learner to the immunology of vaccines and early vaccine development. It provides guidance on regulatory perspectives affecting pre-clinical and clinical trials, and on data requirements in applications for authorisation to market vaccines in the EU and USA. Vaccines are counted amongst the most cost-effective of public health interventions and have had a huge impact on the world's health. Their complex nature, and the diverse immunological responses associated with some, make their development on a global scale difficult, but their production can be lucrative for the small number of manufacturers. This module will prove to be a useful reference for both the scientific and regulatory considerations of vaccine development.";
oModule.status = STATUS_FUTURE;
oModule.duration = 5;
oModule.level = 3;
oModule.objectives = "The learner will gain an understanding of scientific and regulatory aspects of vaccine development.";
oModule.benefit = "All staff working on non-clinical or clinical trials or product development for vaccines, or in regulatory affairs, will find this module useful.";
oModule.addOutline("Vaccines - the basics");
oModule.addOutline("Vaccines in the 21st century");
oModule.addOutline("Vaccines in the prevention of infectious disease");
oModule.addOutline("Conducting clinical trials for global registration");
oModule.addOutline("Applying for approvals in the EU and USA");
oModule.addOutline("Data requirements");
oModule.addOutline("Manufacturing issues");
oModule.addOutline("Setting specifications");
oModule.addOutline("Preclinical issues");
oModule.addOutline("Clinical issues");
oModule.addOutline("Case study");
//oModule.addExpert();
oModule.addCategory();
oModule.audience = "";
oModule.region = "";
arModules[arModules.length] = oModule;

var oModule = new ClsModule();
oModule.code = "";
oModule.title = "Pricing & Reimbursement in the European Union";
oModule.description = "Cost containment and parallel trade are just two considerations that contribute to any price optimisation strategy in the EU. Following EU enlargement, and reforms of the legislative framework and national policies, the task of maximising returns on products whilst remaining competitive has become yet more complex. This module introduces the learner to the fundamentals of pricing and reimbursement. It provides guidance on reference pricing, the impact of parallel trade, and taxation policies in the EU, current issues, EU national healthcare systems, the impact of generics, and product launch strategies. An intermediate to advanced level module, it functions equally as training and reference to assist the experienced practitioner in  this strategically crucial area of pharmaceutical commerce.";
oModule.status = STATUS_FUTURE;
oModule.duration = 4;
oModule.level = 3;
oModule.objectives = "The learner will be able to optimise pricing strategies for medicinal products in the European Union.";
oModule.benefit = "Marketing and sales staff will find this module to be an invaluable training and reference tool.";
oModule.addOutline("Fundamentals of Pricing and Reimbursement");
oModule.addOutline("Pricing in the development process");
oModule.addOutline("Pricing strategy and optimization");
oModule.addOutline("Pricing compliance issues");
oModule.addOutline("Impact of parallel trade");
oModule.addOutline("EU pricing and reimbursement policies");
oModule.addOutline("Impact of enlargement");
oModule.addOutline("Cost containment and taxation policies");
oModule.addOutline("Current issues in Pricing and Reimbursement in the EU");
oModule.addOutline("Pricing and Reimbursement in the EU Member States");
oModule.addOutline("Pricing reforms");
oModule.addOutline("Negotiations and Price determination");
oModule.addOutline("The UK Pharmaceutical Price Regulation Scheme (PPRS)");
oModule.addOutline("Successful Product Launch Strategies for the EU");
oModule.addOutline("Future Trends and Issues");
//oModule.addExpert();
oModule.addCategory();
oModule.audience = "";
oModule.region = "";
arModules[arModules.length] = oModule;

var oModule = new ClsModule();
oModule.code = "";
oModule.title = "Good Laboratory Practice (GLP)";
oModule.description = "Compliance with the principles of GLP is a requirement on pharmaceutical companies and contract research organisations engaged in laboratory studies whose results will be assessed by regulatory authorities, particularly those on the safety of drug substances. This module covers the principles and continuing evolution of GLP and monitors the ongoing developments in regulatory requirements in the EU and USA.<br><br>It provides guidance on the interpretation of the OECD GLP principles, which effectively constitute an international standard, as well as those of the US FDA and Environmental Protection Agency. It may also be used as a workflow support tool.";
oModule.status = STATUS_FUTURE;
oModule.duration = 6;
oModule.level = 1;
oModule.objectives = "Learners will gain an understanding of current GLP requirements and will be able to comply with them in practice.";
oModule.benefit = "This is an essential training course and reference tool for all laboratory staff working in the pharmaceutical industry.";
oModule.addOutline("Roles and responsibilities of study personnel");
oModule.addOutline("Management of multi-site studies");
oModule.addOutline("Study plans/protocols");
oModule.addOutline("Preparation of Standard Operating Procedures");
oModule.addOutline("Animal care");
oModule.addOutline("Quality assurance and inspections");
oModule.addOutline("Equipment and procedures");
oModule.addOutline("Test and reference items");
oModule.addOutline("Data records and reports");
//oModule.addExpert();
oModule.addCategory();
oModule.audience = "";
oModule.region = "";
arModules[arModules.length] = oModule;

var oModule = new ClsModule();
oModule.code = "";
oModule.title = "Registration of Medical Devices in the EU & USA";
oModule.description = "Medical devices range from sophisticated diagnostic equipment to simple bandages. In the European Union the registration of such devices is governed by the Medical Devices Directives and involves Competent Authorities, Notified Bodies and the CE mark. In the USA the FDA operates a system of medical device master files and Quality System Regulation. Manufacture is subject to the provisions of Good Manufacturing Practice. This module provides an overview of requirements and issues related to the development and registration of medical devices. It discusses the 2003 changes in the FDA's approach to medical device regulation and reviews the ongoing consequences of these changes in practice. It will equip staff involved in the design, manufacture and quality control of medical devices with an understanding of the relevant regulatory requirements relating to registration. Clinical investigation and post-market surveillance are also covered. In addition, topics such as the EUDAMED database and the Global Medical Device Nomenclature system are discussed.";
oModule.status = STATUS_FUTURE;
oModule.duration = 5;
oModule.level = 1;
oModule.objectives = "Learners will understand the key issues affecting the development of medical devices. They will gain familiarity with the requirements for their registration and post-market auditing and reporting in the EU and the USA.";
oModule.benefit = "All those involved in the design, trials, registration, manufacture and quality control, and post-manufacturing surveillance of medical devices will find this module an invaluable foundation course and reference tool.";
//oModule.addOutline("");
//oModule.addExpert();
oModule.addCategory();
oModule.audience = "";
oModule.region = "";
arModules[arModules.length] = oModule;

var oModule = new ClsModule();
oModule.code = ""; //"CS01";
oModule.title = "Principles of Current Good Practice for Computerised Systems in GxP Regulated Environments";
oModule.description = "The use of IT systems is now considered essential in most areas of the Life Science industries.  For those companies supplying the US market, the requirements for security and validation of such systems are enshrined in the Code of Federal Regulations (CFR) Title 21 Part 11 - legislation simply referred to as 'Part 11'. The module provides an overview of Part 11, followed by detailed explanation of each section. This covers all aspects of the regulations, including electronic and digital signatures as well as electronic records, access control, audit trails, and biometric signatures such as retina scanning. The risk associated with implementing a bespoke system clearly differs from that for an off-the-shelf industry standard. The module explains the different categories of software and the implications of using each. This is an evolving area of legislation, and our industry experts will ensure that this evolution is reflected in frequent updates to the module.";
oModule.status = STATUS_FUTURE;
oModule.duration = 5;
oModule.level = 3;
oModule.objectives = "Learners will become familiar with the requirements of 21 CFR Part 11 and will be able to implement them in practice.";
oModule.benefit = "All those responsible for the use or supply of IT systems in the US Life Science industries will find this module to be an invaluable training course and reference tool.";
//oModule.addOutline("");
//oModule.addExpert();
oModule.addCategory();
oModule.audience = "";
oModule.region = "";
arModules[arModules.length] = oModule;

var oModule = new ClsModule();
oModule.code = "";
oModule.title = "Regulation of Pharmaceuticals Promotion in the USA";
oModule.description = "The promotion and marketing of pharmaceuticals is regulated more tightly than that of any other products. All pharmaceutical companies must have a detailed knowledge of regulatory constraints on these activities. Due to the commercial impact of change in this field, it is essential to understand not only the fundamentals but to be equipped with the means to access new developments as and when they occur. This module serves as an excellent training and knowledge support tool for the beginner and the more experienced. Although the USA's drug regulations are among the most stringent, it allows marketing direct to the consumer for prescription products, unlike most other countries. This course provides a guide to the US regulations on promotion and marketing of prescription drug products to healthcare professionals and consumers. It also deals with marketing of over-the-counter products. Issues addressed include: print and broadcast advertising; internet advertising, e-detailing and websites; wording and layout in advertisements and publications; Prescribing Information and labelling; reminder adverts; avoidance of minimisation of risks, 'off-label' promotion, and unsubstantiated claims; the role of the FDA and the role of the Federal Trade Commission.";
oModule.status = STATUS_FUTURE;
oModule.duration = 5;
oModule.level = 1;
oModule.objectives = "Learners will gain an understanding of the US regulations on pharmaceuticals promotion and will be able to comply with them in practice.";
oModule.benefit = "All marketing personnel involved in promoting pharmaceuticals for the US market will find this module an invaluable training course and reference tool.";
//oModule.addOutline("");
//oModule.addExpert();
oModule.addCategory();
oModule.audience = "";
oModule.region = "";
arModules[arModules.length] = oModule;


/*
var oModule = new ClsModule();
oModule.code = "";
oModule.title = "";
oModule.description = "";
oModule.status = -1;
oModule.duration = ;
oModule.level = -1;
oModule.objectives = "";
oModule.benefit = "";
oModule.addOutline("");
oModule.addOutline("");
oModule.addExpert();
oModule.addCategory();
oModule.audience = "";
oModule.region = "";
arModules[arModules.length] = oModule;
*/

//### future ###
createFutureModule("An Introduction to Clinical Trials");
createFutureModule("Clinical Trial Management");
createFutureModule("Good Document Management Practice");
createFutureModule("Introduction to the Drug Approval Process in the US");
createFutureModule("ANDA submissions");
createFutureModule("Annual Reports");
createFutureModule("Changes to Approved NDA and ANDA Documents");
createFutureModule("Gaining IND Approval");
createFutureModule("Gaining NDA Approval");
createFutureModule("Approval of Abbreviated/Abridged Products in the USA and EU");
createFutureModule("Essentials of Regulatory Affairs in Australia and New Zealand");
createFutureModule("Essentials of Regulatory Affairs in Canada");
createFutureModule("Essentials of Regulatory Affairs in China");
createFutureModule("Essentials of Regulatory Affairs in the Far East");
createFutureModule("Essentials of Regulatory Affairs in India");
createFutureModule("Essentials of Regulatory Affairs in Latin America");
createFutureModule("Essentials of Regulatory Affairs in Middle East and Africa");
createFutureModule("Essentials of Regulatory Affairs in Non-EU European Countries");
createFutureModule("Essentials of Regulatory Affairs in Switzerland");
createFutureModule("European Drug Master Files & Certificates of Suitability");
createFutureModule("Implementation of Information Technology in Regulatory Affairs");
createFutureModule("Labelling and Patient Information in the EU & USA");
createFutureModule("Legal Classification of Medicinal Products and Switch Procedures");
createFutureModule("Maintenance & Compliance");
createFutureModule("Management of Regulatory Affairs and Strategic Planning");
createFutureModule("Named Patient Use");
createFutureModule("New Drug Development");
createFutureModule("Optimising the Contribution of Regulatory Affairs to Product Development, Maintenance and Commercialisation");
createFutureModule("Pre-Clinical Development of Medicinal Products");
createFutureModule("Preparing for GMP Audit by EU & FDA Inspectors");
createFutureModule("Product Life-cycle Management");
createFutureModule("Registration of Herbal Products in the EU & USA");
createFutureModule("Registration of Homeopathic Products in the EU & USA");
createFutureModule("Safety reporting in pharmacovigilance");
createFutureModule("Statistics for the Non-specialist");
createFutureModule("Supply Chain & Parallel Importation");



function createFutureModule(sModuleName)
{
	var oModule = new ClsModule();
	oModule.code = "";
	oModule.title = sModuleName;
	oModule.description = "";
	oModule.status = STATUS_FUTURE;
	oModule.duration = 0;
	oModule.level = "";
	oModule.objectives = "";
	oModule.benefit = "";
	oModule.addOutline("");
	oModule.addOutline("");
	//oModule.addExpert();
	//oModule.addCategory();
	oModule.audience = "";
	oModule.region = "";
	arModules[arModules.length] = oModule;
}

//SortModules();