Regulatory Affairs and Safety

Objectives

1. Understand the principles of regulation of medicines and health products and the role of national and international regulatory authorities.

2. Know the regulatory systems in place in Europe and to identify special regulatory requirements in Portugal.

3. Understand the purpose of the information contained in the summary of product characteristics, labeling and package leaflet.

4. Know the specific rules applicable to the authorization of medicines for populations at risk, advanced therapies, biotechnology and biological products, orphan drugs, generics and biosimilars, vaccines, herbal and homeopathic products, cosmetics, veterinary drugs and medical devices.

5. To understand the importance of evaluation and drug safety monitoring. and risk assessment.

6. Know the studies of Post-Authorisation in the market, safety and efficacy.

7. Develop the ability to self-learning and research of appropriate information.

8. Demonstrate appropriate capacities for synthesis and communication.

General characterization

Code

191006

Credits

Responsible teacher

Prof.ª Doutora Maria Teresa Ferreira Herdeiro

Hours

Weekly - Available soon

Total - Available soon

Teaching language

Portuguese or English

Prerequisites

Bibliography

· Council of Europe. (2008). European pharmacopoeia. Strasbourg: Council of Europe.

· Decreto-Lei n.º 20/2013, de 14 de fevereiro do Ministério da Saúde. Diário da República: I série, No 20 (2013).

· EMA. (2016). http://www.ema.europa.eu/ema/

· EMA. (2016). Good pharmacovigilance practices. Disponível em: http://www.ema.europa.eu/ema/index.jsp?

· curl=pages/regulation/document_listing/document_listing_000345.jsp.

· European Commission. (2016). Pharmaceutical Legislation Notice to applicants and regulatory guidelines

· Medicinal products for human use. Disponível em: http://ec.europa.eu/health/documents/eudralex/vol-

· 2/index_en.htmICH. (2016). http://www.ich.org/home.html

· Índice Nacional Terapêutico. Disponível em: https://www.indice.eu/pt/indices/indice-nacional-terapeuticocompendio/

· Apresentacao-indice-nacional-terapeutico-compendio

· Infarmed. (2016). www.infarmed.pt

Teaching method

The teaching methodology is adapted to its classes (1S/2TP). Expository lecturers and seminars, recurring whenever possible to the critical analysis of case-studies presented during the class. The presented contents will be used in group work in the critical analysis of case studies.

Evaluation method

The CU is development in discrete evaluation methodology with 2 written exams (80%) and 1 group report (20%).

Subject matter

1. European and national regulatory system for medicines for human use.

2. Authorisation procedures on the market in the European Union and national level: Centralized, Mutual Recognition, Decentralized and National.

3. Alternative authorization processes.

4. New paradigms: Challenges of "Adaptive pathways" and the PRIME program.

5. Drug Marketing Authorisation Dossier (Common Technical Document).

6. Drugs for Rare Diseases - Orphan.

7. Advanced Therapies and Vaccines.

8. Medicinal Products for Pediatrics and Geriatrics.

9. Generics and Biosimilars.

10. Veterinary medicines.

11. Homeopathic medicines and traditional herbal medicinal.

12. Medical Devices and body care and cosmetics products.

13. System risk management of medicines, pharmacovigilance, cosmetovigilance and surveillance of medical devices.

14. Post-authorization studies.

15. The process of scientific advice.

Programs

Programs where the course is taught:

Master in Clinical Research Management