EU (European Union) Proposed Pharmaceutical Legislation Changes Training Course

Overview

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.

This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.

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

Who Should Attend

The course is designed primarily for regulatory affairs personnel, however, it will also be of value to those who interact with the regulatory affairs function and would benefit from an understanding of action timelines and strategic factors. It will be of interest to personnel working in:

• Regulatory affairs
• Project management
• Business planning
• Commercial management
• Labelling and artwork
• Medical information
• Manufacturing and QA

Enrol or reserve