EU Proposed Pharmaceutical Legislation Changes
It is essential that companies are aware of proposed changes to pharmaceutical legislation in the EU and the potential impact on company planning and strategy.
The UK is no longer a member of the EU but knowledge of interactions and collaboration with the EU are important for obtaining and maintaining marketing authorisations in the UK and the EU.
The programme will cover the current legal basis of pharmaceuticals regulation in the EU and proposed changes in pharmaceuticals legislation. The proposed changes in procedures for obtaining marketing authorisation in the EU and post-authorisation data and marketing protection will be considered. The changes in the role and responsibilities of the EMA will be discussed.
The format will provide opportunities for discussion and for sharing of concerns and experiences with our expert trainer and other delegates.
Upcoming start dates
Suitability - Who should attend?
Benefits of Attending
- Understand the legal basis of the EU regulatory environment
- Discuss proposed changes to EU Pharmaceuticals legislation
- Review current and proposed procedures for applying for a marketing authorisation in the EU/EEA and in the UK
- Consider post-authorisation data and marketing protection
- Learn about proposed changes to the EMA responsibilities and function
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