Μ7. Regulatory framework for the approval of medicinal products and clinical studies
Purpose/Objectives of the Course
Within the framework of the course, the following thematic modules are developed: The drug as a product and social good from its discovery until it reaches the user – patient. Legal parameters. Existing regulatory framework (Laws, Community Medicines Code, other Regulations and Union Directives, International Conventions). Drug market and its specificities, mainly from the point of view of free competition. E-commerce of medicines. European Pharmaceutical Regulatory Environment, European Pharmaceutical Legislation. Regulatory framework for drug approval, general dossier requirements, specific requirements per category. Biosimilars and Orphan drugs. Regulatory framework for clinical trials of medicinal products intended for humans. Pharmacies. GMP Good Manufacturing Practices. Pharmacovigilance: regulatory framework and drug development. Liability issues related to the production and circulation of medicines. Patents and drugs. The function of the pharmacist in the EU and Greece, based on legislation and jurisprudence. Drug distinctions and their significance for the law (generic and reference drugs, prescription drugs, orphan drugs). Health Technology Assessment. The European and Greek Reality for Galenic preparations. Regulatory framework for nutritional supplements, cosmetics and medical technology products.
Coordinator
| Image | Name | Designation | Contract Info | Social Links |
|---|---|---|---|---|
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Vizirianakis Ioannis | Associate Professor of Molecular Pharmacology and Pharmacogenomics | ivizir@pharm.auth.gr 2310997658 |
Teachers
| Image | Name | Designation | Contract Info | Social Links |
|---|---|---|---|---|
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Kafkala Styliani | MSc, cPhD | ||
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Kontogiorgis Christos | Assistant Professor | ckontogi@med.duth.gr 2551030601 | |
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Moraiti Aikaterini | PhD | ||
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Moutafidou Nikoleta | MSc | ||
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Papanikolaou Nikolaos | |||
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Papatheofanous Ioanna | |||
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Tziva Evmorfia | Professor of Trade and Financial Law | efmtziva@law.auth.gr 2310996618 | |
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Vizirianakis Ioannis | Associate Professor of Molecular Pharmacology and Pharmacogenomics | ivizir@pharm.auth.gr 2310997658 |
Course Organization
ECTS: 6
Lectures: 10
Workload
150 – 180 hours
Lectures/Workshops: 53 hours
Personal effort: 97 hours
Course Lectures
Week | Faculty | Teaching method | Description of teaching unit |
1 | Jiva Effie Professor of Law AUTH | Theory | European and Greek pharmaceutical law. Important aspects of the regulatory framework of drugs approval and marketing . |
2 | Prodromou Sofia Chemist, MSc, cPhD Center for Digital Innovation Phizer | Theory | Drug Development and discovery, Good clinical practice for clinical trials, Diversity in Clinical trials, Pediatric Research – Pediatric Clinical Operations |
3
| Vizirianakis Ioannis Asst. Prof. of Pharmacology, AUTH | Theory | Pharmacovigilance: regulatory framework and drug development |
4 | Papatheofani Joanna Senior Manager Quality Technical Support Chemist BS, RQAP GLP Rafarm S.A. | Theory | GMP Good Manufacturing Practices. Purpose and principles of GMP, with particular emphasis on data integrity (from an industry perspective) |
5 | Giannakou Stergiani,I nspections Department, Division of Production & Distribution Control, National Organization for Medicines | Theory | Good Manufacturing Practices – Good Manufacturing Practices: Systemic Approach – Regulatory Compliance – Practical Implementation (Part I) |
6 | Giannakou Stergiani, Inspections Department, Division of Production & Distribution Control, National Organization for Medicines | Theory | Good Manufacturing Practices – Good Manufacturing Practices: Systemic Approach – Regulatory Compliance – Practical Implementation (Part II) |
7 | Moraiti Catherine Pharmacist, PhD., Director of NΟΜ, member of CHMP, COMP, EMA. | Theory | General dossier requirements, specific requirements per category Biosimilars and Orphan medicines Health Technology Assessment, ΗΤΑ (Health Technology Assessment) Part I |
8 | Moraiti Catherine Pharmacist, PhD., Director of NΟΜ, member of CHMP, COMP, EMA. | Theory | General dossier requirements, specific requirements per category Biosimilars and Orphan medicines Health Technology Assessment, ΗΤΑ (Health Technology Assessment), Part ΙI |
9 | Kafkala Stella, MSc, cPhD, Analytical Development Director, Genepharm | Theory | Contents of file submitted to the National Organization for Medicines. Emphasis on detailed data : Dossier sections (modules and sections) |
10 | Papanikolaou NikosHead of Quality Operations Dept. Boehringer Ingelheim
| Theory | Quality Control in the pharmaceutical industry: a) Regulatory framework b) Categories of analyzes (routine testing, process validation, cleaning validation, analytical method validation/verification, stability studies), c) Transfers of analytical methods d) Data integrity in the laboratory e )Internal & external inspections in Quality Control |
11 | Kontogiorgis Christos, Assistant Professor D.U.Th. | Theory | Introduction to Pharmacoepidemiology – Methodology |
12 | Kontogiorgis Christos, Assistant Professor D.U.Th. | Theory | Pharmacoepidemiological studies – Examples of development and assessment of the use of approved medicines |
13 | Nicoleta Moutafidou, Professionals Program, European Patent Office | Theory | Formation of a deposit file at the National Organization for Medicines |
14 | Nicoleta Moutafidou, Professionals Program, European Patent Office | Theory | Patent filing process |
15 | Exams /Theory | ||
Final Exam
Related Bibliography
- Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use – https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX%3A32001L0083
- Directive 2001/83/EC Consolidated Version – https://www.gmp-compliance.org/files/guidemgr/Directive 2001_83_EC 2019.pdf
- Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency – https://eur-lex.europa.eu/eli/reg/2004/726/oj
- The European Medicines Agency is a Decentralised agency of the European Union in charge of the evaluation and supervision of pharmaceutical products. – https://www.ema.europa.eu/en/homepage
- The Agency’s main responsibilities are authorising and monitoring medicines in the EU. Companies apply to it for a single marketing authorisation, which is issued by the European Commission. – https://european-union.europa.eu/institutions-law-budget/institutions-and-bodies/search-all-eu-institutions-and-bodies/european-medicines-agency-ema_en