Modules of the 4th Course
MODULE 1: AN OVERVIEW – PRINCIPLES OF THE DISCOVERY & DEVELOPMENT PLANNING OF MEDICINES
26-29 October, 2017 – Budapest
Learning outcomes. At the end of this Module the student should be able to demonstrate an understanding of the: 1. Process of drug development and identity of critical factors and decision points. 2. Importance of the patient in drug development. 3. Background to the development of the regulation of medicines and the role of the competent authorities. 4. Monitoring of drug safety. 5. Principles and practice of medical marketing. 6. Role of pathophysiology and molecular biology-based pharmacology in drug development. 7. Principal steps in discovering, modifying, assessing and patenting new chemical and biological compounds (including advanced therapies) according to their therapeutic indication. 8. Resource planning (in terms of project management, budgeting and cost-control) involved in the management of a drug development programme. 9. Principles of translational research and its role in drug development. 10. Functions and elements (including business aspects) involved in the integrated development of a new drug.
MODULE 2: NON-CLINICAL AND EARLY CLINICAL DEVELOPMENT
30 November – 3 December, 2017 – Ljubljana
Learning outcomes. At the end of this Module the student should be able to demonstrate an understanding of the: 1. Choice and predictive value of the non-clinical testing programme as part of the overall drug development plan for chemical and biological compounds. 2. Integration of non-clinical tests into the overall drug development plan (including scheduling of toxicology tests with respect to clinical trials).3. Steps in the pharmaceutical development of a drug substance and final drug product (including chemical and biological compounds).4. Planning of clinical trial supplies for test substance and comparators (active and placebo).5. Overview of non-study requirements prior to First-into-Man studies. 6. Molecular and cellular basis of toxic reactions. 7. Principles and practical application of pharmacokinetics and toxicokinetics. 8. Early exploratory development in man. 9. Principles of clinical pharmacology and their application to clinical development. 10. Influence of genetic factors in drug development and drug response.
MODULE 3: CLINICAL DEVELOPMENT OF MEDICINES: EXPLORATORY AND CONFIRMATORY
1-4 March, 2018 – Budapest
Learning outcomes. At the end of this Module the student should be able to demonstrate an understanding of: 1. Early studies in patients: dose-finding / proof of concept studies and their impact on drug development plan. 2. Clinical trial design (including legal, regulatory, ethical and practical aspects): international differences. 3. Principles and application of statistics in clinical trials. 4. Procedures for clinical trial data collection (paper and electronic) and data management (including validation processes) to ensure optimal quality data. 5. Key strategic issues in the clinical trial process, in terms of legislative requirements and Good Clinical Practice (GCP). 6. The role of the investigator drug brochure (IDB).7. Principles and practical relevance of ethical issues in biomedical research. 8. Legal and ethical provisions for protection of clinical trial subjects.
MODULE 4: CLINICAL TRIALS
24-27 May, 2018 – Budapest
Learning outcomes. At the end of this Module the student should be able to demonstrate an understanding of the: 1. Various types of clinical studies and the methods used to choose the appropriate design. 2. Main statistical methods used in clinical research. 3. Key issues involved in the conduct of a clinical study including investigator and site recruitment, investigative site management and conflict resolution. 4. Collection, evaluation and reporting of adverse event data in clinical trials. 5. Various quality management issues in clinical trials. 6. Impact of emerging results on the drug development plan. 7. Key operational and strategic issues in the clinical development plan. 8. Evaluation of the outcome of drug development: final therapeutic profile / usage of a medicine. Evidence Based Medicine. 9. Role of the Target Product Profile (TPP) and Target Product Claims (TPC). 10. Role of the Drug Safety Monitoring Board (DSMB) and other relevant study committees. 11. Statistical issues in statistical report writing. 12. Evaluation and interpretation of clinical trial results. 13. Principles and practical application of critical appraisal.
MODULE 5: REGULATORY AFFAIRS; DRUG SAFETY and PHARMACOVIGILANCE
11-14, October 2018 – Bratislava
Learning outcomes. At the end of this Module the student should be able to demonstrate an understanding of: 1. General principles of medicines regulation (both pre- and post-approval) at EU and global level. 2. Impact of medicines legislative requirements on regulatory activities within a pharmaceutical company. 3. Role of national agencies and international bodies in medicines regulation. 4. National provisions for management of (1) off-label / unlicensed use of medicines (2) controlled drugs. 5. Place of International Conference on Harmonisation (ICH) in medicines regulation (including Common Technical Document [CTD]). 6. Regulatory processes in the EU / EEA areas. 7. Regulation and legal considerations of Product Information. 8. Principles and practical application of medical devices regulation. 9. Roles of the various stakeholders (including pharmaceutical and other healthcare professionals, investigators, regulatory authorities) in drug safety and pharmacovigilance. 10. Classification of adverse events / adverse drug reactions. 11. Safety reporting requirements (according to the type of adverse event / reaction) pre- and post-approval. 12. Ongoing management of drug safety issues pre- and post-approval (including Risk Management Plans [RMPs], Periodic Safety Update Reports [PSURs]); ongoing benefit / risk assessment throughout the life-cycle of a medicine. 13. Role of pharmacoepidemiology in the life-cycle management of a medicine. 14. Factors influencing medication safety from the perspective of each stakeholder.
MODULE 6: HEALTHCARE MARKETPLACE; ECONOMICS OF HEALTHCARE
29 November – 2 December, 2018 – Budapest
Learning outcomes. At the end of this Module the student should be able to demonstrate an understanding of: 1. Life-cycle activities (clinical, regulatory and marketing). 2. Processes of production and review of product information to ensure adherence to ethical and legal principles pertaining to marketing activities (Good Promotional Practice). 3. Role of patient organisations. 4. Principles and practical application of health economics and patient-reported outcomes within the pharmaceutical industry. 5. Principles of health technology assessment (HTA) and its role in the supply of medicines to the marketplace. 6. Principles and practice of marketing within the pharmaceutical industry. 7. Drug budget control; pricing mechanisms. 8. Explain the multidisciplinary nature of pharmacoeconomics and ethical boundaries, and the need for integration of knowledge from a range of health science disciplines in the management of sustainable health service challenges in the 21st century. 9. (ELM) Use in an appropriate manner the fundamental scientific theories underlying the application of health economic techniques to a range of healthcare interventions. 10. (ELM) Recognise and be capable of utilising basic relationships and techniques of healthcare management to maximise benefits from a given resource. 11. (ELM) Explain and present information associated with economic appraisal and assessment of new medicines carried out by NICE or similar agencies. 12. (ELM) Explain the role of the agencies which police the economic viability of existing and new medical technologies. 13. (ELM) Compare and contrast the different challenges of healthcare expenditure presented in different economies. 14. (ELM) Outline the structure of the global drug development and regulatory framework with emphasis on risk management in the context of benefit/risk assessment and the role of pharmacoeconomics and quality-of-life, and be capable of explaining its evolution, strengths and weaknesses. 15. (ELM) Explain methods utilised in clinical trials for examining cost-effectiveness of new pharmaceutical products.
MODULE 7: BIOLOGICALS AND ADVANCED THERAPIES
7-10 February, 2019 – Budapest
Learning outcomes. At the end of this Module the student should be able to demonstrate an understanding of the: 1. Demonstrate an understanding of the regulatory, ethical and legal issues that are peculiar to biological and advanced therapies. 2. Demonstrate an understanding of the challenges presented in constructing a package of non-clinical data to support the clinical development and marketing of biological and advanced therapies. 3. Recommend a clinical trial plan that is appropriate for the different types of products and technologies represented by biological and advanced therapies. 4. Demonstrate an understanding of the technical and manufacturing issues that are peculiar to biological and advanced therapies. 5. Critically review general articles on new or prospective biological or advanced therapies, and published papers describing the clinical trials of biological and advanced therapies. 6. Describe the new technologies now available and those in development; describe the therapeutic opportunities that might arise from the technology. 7. Critically analyse the differences between natural and modified proteins. 8. Describe the global need for new and improved vaccines and the barriers to their development. 9. Describe what a therapeutic vaccine is and how it could influence therapy in a common disease area. 10. Discuss the history and future prospects for gene therapy, and the technical difficulties developing a gene therapy product. 11. Describe the concept of stem cell therapy, what opportunities it might present, and the ethical issues that are unique to this technology. 12. Describe the particular ethical and regulatory issues of advanced therapies and how The Advanced Therapy Directive is addressing these.
MODULE 8: GENERIC & BIOSIMILAR MEDICINAL PRODUCTS
16-19 May, 2019 – Budapest
Learning outcomes. At the end of this Module the student should be able to demonstrate an understanding of the: 1. Compare & appraise the scientific & regulatory basis for the definitions of the various types of follow-on drugs: generic, biosimilar & analogue medicinal products, define their significance in the life-cycle management of medicines. 2. Specify the right timing of pharmacokinetic studies during generic drug development. 3. Select the appropriate “in vivo” methods to establish equivalent bioavailability of generic drugs. Assess the significance of food & alcohol interactions in bioequivalence studies. 4. Assess the scientific basis & methods used for the “in vitro” equivalence estimation of generic drugs. 5. Analyse the diversity caused by the development of independent formulations for the same active ingredients by the follow-on producer; added-value generics.6. Critically review the international regulatory differences in the evaluation of marketing authorisation applications for generic products. 7. Appraise the causes leading to the diversity of the biosimilar medicinal products manufactured by different producers. 8. Evaluate the complex non-clinical & clinical comparative study requirements needed to evaluate the biological & immunogenic properties of biosimilar drugs. 9. Recognise the specific production problems of complex biosimilar monoclonal antibodies needed for targeted therapy. 10. Analyse & assess the complexity & international diversity of regulatory requirements for evaluating the efficacy & immunological safety of follow-on biological products. 11. Appraise the various clinical pharmacological issues related to the clinical interchangeability of generic & biosimilar drugs.
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