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.