Regulatory Affairs

Assuntos Regulamentares

Curse code:9494530

Maria Cristina Fortes Toscano

Learning outcomes of the curricular unit:

The aim of the course is to provide the acquisition of skills and knowledge in a comprehensive and systematized form regarding regulation in the area of medicines and health products.

Syllabus:

1. Regulation applicable to medicines
2. Regulation applicable to medical devices
3. Regulation applicable to cosmetic products
4. Regulation applicable to food supplements
5. Pharmacovigilance. Vigilance of medical devices. Vigilance of cosmetics

Suggested 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 (Consolidated version: 16/11/2012)
• EudraLex Volume 1 - Pharmaceutical Legislation Medicinal Products for Human Use
• Eudralex Volume 2 - Notice to applicants and regulatory guidelines for medicinal products for human use
• Eudralex Volume 3 - Scientific guidelines for medicinal products for human use
• Euralex Volume 9 - Guidelines for pharmacovigilance for medicinal products for human and veterinary use