Cooperative European Medicines Development Course
Fourth CEMDC Course 2017-2019
For current and future pharma managers from all countries
The 4th CEMDC course has started in Budapest in October 2017. – The aim of the course is to train experts who understand the complex process of medicines development from molecule to health care and who can apply this knowledge working in large or small, innovative or generic pharmaceutical companies, regulatory agencies, in health care and health research or insurance management. The course material was carefully compiled by academic and industry experts to meet the needs of both the pharmaceutical industry and health care. It covers the 3 main competency areas of medicines development: Drug Development and Clinical Trials; Regulatory Affairs and Safety of Medicines; Health Care and Professionalism. The teaching follows the international, harmonized modular training program and quality standards developed by PharmaTrain. The CEMDC is internationally accredited as a PharmaTrain Center of Excellence. The entire Base Diploma Course contains 8 modules. Certain modules might be presented at other participating universities. Each module lasts 4 days and is finished by an examination. The modules are given in 2-3 month intervals. It is possible to visit only selected modules to satisfy individual educational needs. Students can apply with medical, pharmaceutical, MSc or equivalent degrees in natural and life sciences. The course is open for students of all nationalities. The official language of the course is English. Coordinated by the Semmelweis University, Budapest, Hungary. Participation fee
- 800 EUR per module if the entire course is registered
- 1000 EUR per module if certain module(s) is (are) registered
- Final exam: 500 EUR
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.
General Description of the Course
Learn medicines development from molecule to patients at a PharmaTrain accredited international course organized jointly by 10 regional universities
The course is open for students from all countries.
The need to provide high-quality and cost-effective medication for mankind living in various countries led to the intensive globalization of the research and manufacturing of medicines. The global need for properly educated professionals with a broad education covering all aspects of medicine development can be primarily provided by highly complex life-long continuous professional training. Unfortunately, countries with smaller populations and/or small size pharmaceutical industry cannot provide and maintain this education cost-effectively for a prolonged time. For covering their needs the Cooperative European Medicines Development Course (CEMDC) was organized with the participation of 10 regional universities. The PharmaTrain harmonized European course program is used for the teaching.
PharmaTrain, the European harmonized concept of teaching medicines development
The aim of the course scientifically accredited by PharmaTrain and IFAPP is to train experts who understand the complex process of medicines development from molecule to health care and who can apply this knowledge working in large or small, innovative or generic pharmaceutical companies, enterprises, regulatory agencies in health care and health insurance management. The course material was carefully compiled by academic and industry experts to meet the needs of both the pharmaceutical industry and health care. Who should apply? The target student population is composed of professionals with medical, pharmaceutical, MSc or equivalent degrees in natural and life sciences. Suitable applicants will be accepted from any country. An adequate knowledge of English is necessary in order to follow the lectures, participate in the discussions and complete the various forms of assessments. For admission, students must submit a copy of their degrees, a certificate or any other document proving their knowledge of English, and a CV describing their professional experience if available.
Modules can be visited also individually according to personal training needs. It is suggested that all Base Course modules should be completed together. Individual selection of advanced elective modules is primarily recommended to collect credits for a continuous individual professional development program and/or for obtaining a master level degree.
Structure of the CEMDC education program The Base Course contains 8 modules which provide a complete overview of all drug development related topics listed in the PharmaTrain Syllabus. The 6 consecutive mandatory basic modules are finished by an integrated assessment evaluated centrally according to PharmaTrain harmonized criteria. Following a successful examination the students receive a Diploma in Medicines Development. The overall learning outcome: at the end of the Base Course the students should be able to understand and apply the basic principles of medicines development science in their working practice. The PharmaTrain accredited Base Course modules are presented uniformly by each PharmaTrain associated centers. Advanced elective modules: in addition to the Base Course, the CEMDC and also the other PharmaTrain course providers offer PharmaTrain accredited elective modules offering a more detailed knowledge and competence in various fields of medicines development. These advanced modules can be freely selected according to individual professional needs. Each basic and advanced elective module will be evaluated separately permitting the transfer of credits between PharmaTrain accredited courses. The modular teaching concept: each module has several PharmaTrain defined learning outcomes which have to be fulfilled uniformly by each course provider. The completion of each module requires 25-30 hours of face-to-face sessions delivered within 4 days every third month. At these meetings the students listen to review lectures, participate in case discussions and tutorial workshops. The direct contact teaching is preceded by extensive home learning of E-modules and selected materials as well as preparatory reading for the team works at the joint sessions. The multiple choice question (MCQ) examination at the end of each module is primarily based on the home learning. In addition, following the face-to-face meeting the students have to submit 1 or 2 assignments consisting of 1200 words. The final note of a module will be based on the joint evaluation of the MCQ examination and the assignments. A failed MCQ examination session can be repeated at the time of the next module. Base Course Modules
- MODULE 1a. INTRODUCTORY PROGRAMME & MODULE 1b. PRINCIPLES OF DISCOVERY OF MEDICINES AND DEVELOPMENT PLANNING
- MODULE 2: NON-CLINICAL, PHARMACEUTICAL AND EARLY CLINICAL DEVELOPMENT
- MODULE 3: CLINICAL DEVELOPMENT OF MEDICINES: EXPLORATORY AND CONFIRMATORY
- MODULE 4: CLINICAL TRIALS
- MODULE 5: REGULATORY AFFAIRS; DRUG SAFETY and PHARMACOVIGILANCE
- MODULE 6: HEALTHCARE MARKETPLACE; ECONOMICS OF HEALTHCARE
- MODULE 7: BIOLOGICALS AND ADVANCED THERAPIES
- MODULE 8: GENERIC & BIOSIMILAR MEDICINAL PRODUCTS
Organization and location of the modules. All educational activities will be carried out in English. The students will be organized into a single international group and will be taught at the same location at the same time. The face-to-face teaching sessions of the various modules may be held at different locations in various participating countries. The international teaching faculty will be selected from academic, industrial and regulatory experts working primarily in Europe. The participation of teachers working in the region will be especially encouraged. Download: SOP3 CEMDC_Version 3, Student Information_ 20130330 Advanced Course Modules PharmaTrain accredited elective modules presented by various PharmaTrain associated course providers. A steadily growing number of advanced elective modules will be presented by the various course providers at different time points. These modules offer more detailed additional information compared to the base modules on specific drug development issues. Some modules might be taught by several courses or presented in cooperation by PharmaTrain accredited partners. For additional information please consult the PharmaTrain website www.pharmatrain.eu and/or the PharmaTrain section of the CEMDC website. Elective modules to be presented by the CEMDC
- Biologicals and advanced therapies
- Generic and biosimilar medicinal products
- Special populations; clinical trial practice and regulation
Tuition fee The CEMDC is a non-profit organization. The participation fee will primarily cover the traveling and local accommodation costs of the international lecturers.The tuition fee will be defined separately for each course. The participation fee should be paid in two parts according to agreement. In addition, the students have to pay their travel and local accommodation expenses. (The organizers will try to make special arrangements for affordable lodging during the modules). Please note that the price is mainly determined by the travel and accommodation expenses of the international team of lecturers. According to international experience, many pharmaceutical companies and other organizations might offer financial support for their employees to visit such courses. In some cases, primarily for students working in non-profit organizations a reduction of the tuition fee might be granted by the Governing Board of the CEMDC. In general, the Basic Course will be provided every second year. Advanced elective modules will be presented parallel with the Basic Course but at different dates not interfering with the presentation of the basic modules.
Fitting the needs of health care and the pharmaceutical industry
In close cooperation with experts from various fields, PharmaTrain has established 180 teaching topics along the road from molecule to the market place. This comprehensive Syllabus of Medicines Development is mapped to 60 Learning Outcomes representing the requirements of the society.
Trainee’s competence profile
The PharmaTrain Syllabus/Learning Outcomes’ approach allows profiling the competences of employees and professional trainees, respectively. Comparing the actual versus a target profile reveals deficits that can be filled by taking PharmaTrain recognised training modules.
Thanks to the international organisation of the program and its connection with the PharmaTrain harmonised training project the CEMDC can guarantee the favourable recognition of its diploma at the international level.
Standard Operation Procedure CEMDC Student Information
Download: PharmaTrain Syllabus_V013_Clean_2010
All the CEMDC related activities are coordinated by the Semmelweis University, Budapest, Hungary.
CEMDC Cooperative European Medicines Development Course Semmelweis University, Department of Pharmacology and Pharmacotherapy
Nagyvárad tér 4. H-1089 Budapest, Hungary
Study Director: Dr. S. Kerpel-Fronius, Email: firstname.lastname@example.org; mobile:+36204790380