Webcast Series: Legal Issues in Regulatory Affairs
Legal basis for marketing authorisations
16.02.2021
15:00 CET
Marketing Authorisation Application & Lifecycle
Legal basis for marketing authorisations
- Full dossier
- Abridged procedures for generics, hybrid application and literature-based applications
Legal questions in marketing autho-risation and lifecycle management
- Marketing authorisation with conditions
- Deadlines in the various procedures - what to be done if missed?
- Lifecycle management: variation not approved
Host
FORUM Institut für Management GmbH