Marketing Authorisation Procedures in the EU
09.04.2025
from 09:00 -17:00
You may dial-in 30 minutes before
Dr. Christian Moers und Weitere
This seminar provides an in-depth exploration of EU drug marketing authorisation, focusing on regulatory frameworks, application types and procedures. It covers mutual recognition, decentralised and centralised procedures (MRP, DCP, CP) in detail, providing essential insights for successful EU drug approval.
Topics
- EU regulatory framework and legal basis
- Mutual recognition and decentralised procedures (MRP and DCP)
- Centralised procedure (CP)
- Specifics for generic drug approvals
Who should attend
This seminar is intended for professionals involved in the drug approval process needing in-depth knowledge of European approval procedures. It is specifically tailored for beginners and career changers.
Aims and objectives
This seminar provides a comprehensive understanding of EU drug marketing authorisation procedures.
Participants will explore the regulatory framework, various application types, and detailed application procedures, gaining essential insights into navigating EU drug approval complexities.
Your benefit
- In-depth knowledge of EU regulatory framework and marketing authorisation procedures
- Insights into the roles and functions of relevant authorities and committees
- Strategies for mutual recognition and decentralised procedures
- Detailed understanding of the centralised procedure and scientific advice process
- Specific information on data exclusivity, innovation protection and requirements for generics
Host
FORUM Institut für Management GmbH