Strategies to Ensure Compliance with Current Registration Requirements and How to Avoid Pitfalls of New EU Regulations

A Two-day Comprehensive & Interactive Course, with Workshops on:

- Regulatory Authorities and Medicines Control
in the EU
- Revieiwing and Understanding of Official
Regulatory Policies
- Structure and Role of EMEA
- Knowing Key Issues Pertinent to a Successful
EU Regulatory Strategy
- Review of Recent Paediatric Legislation and
Incentives
- Clinical Trail Regulations in Europe
- The Centralised Procedure (CP) vs
Decentralised Procedure (DCP)
- The Mutual Recognition Procedure (MRP)
- Marketing Authorisations Application (MAA)
- National Registration Procedures (NP) in the
EU
- Post-Approval Obligations
- Sunset Clause
- Periodic Safety Update Reports
- Working and Communicating effectively with
the EMEA