Regulatory Affairs
Assuntos Regulamentares
Course 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:
- Regulation applicable to medicines
- Regulation applicable to cosmetic products
- Regulation applicable to food supplements
- Pharmacovigilance. Vigilance
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