The Regulatory Affairs for Support Staff covers topics such as:
- The background of EU Law regulations, directives etc
- The drug development process, from drug discovery to product approval
- The impact of EU Clinical Trials Regulation
- Where you can find information on regulatory affairs, approvals, withdrawals etc
- How to apply for a Marketing Authorisation in the EU the Centralised, Decentralised and Mutual Recognition Procedures
- The Common Technical Document
- Post authorisation obligations pharmacovigilance, variations and renewals
The next Regulatory Affairs for Support Staff will be held on 29-30 Jan 2024.
