EU Drug Regulatory Affairs
Published 8/2026
MP4 | Video: h264, 1920x1080 | Audio: AAC, 44.1 KHz, 2 Ch
Language: English | Duration: 1h 21m | Size: 638.25 MB
A practical introduction to Drug Regulatory Affairs in the European Union
What you'll learn
Understand the EU/EEA regulatory landscape and how medicines are classified within the European framework.
Learn key authorization routes: centralized, decentralized, mutual recognition, and national procedures.
Explain the main types of medicinal products, including generics, biologics, biosimilars, ATMPs, herbal medicines, and homeopathic medicines.
Meet the key agencies and stakeholders driving the EU regulatory system and decisions.
Discover how to prepare an MAA: dossier structure (CTD...