Regulatory Affairs Online-Ausbildung
19.11.2020
10:00-12:00 Uhr
Teil 1: Zulassungsverfahren
e-Learning: Introduction to EU Marketing Authorisation
- Module 1: Overview of the law and EU regulatory network
- Module 2: Principles (The European Economic Area & the scope of Directive 2001/83/EC)
- Module 3: Procedures (MRP, DCP, CP, Referrals)
- Module 4: Application types (legal basis, CTD requirements, Generics, Herbals)
- Module 5: Post authorisation (Renewals, Sunset Clause, Variations)
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Host
FORUM Institut für Management GmbH