European Post Marketing Pharmacovigilance - Including the EMA/PRAC Deliberations and Brexit Implications

This course provides a comprehensive overview of key post-market pharmacovigilance activities required as the foundation for further understanding of new EU legislation that was introduced in 2012 and has undergone over 20 updates in the last 10 years.

The course intends to show how the safety of products is managed at the Regulatory Authority level, the interactions with Regulatory Bodies and Pharma, and the internal Pharma processes in managing the safety of the Company products from receiving safety cases/information, all the way through to signal analysis and safety communication. All of this is viewed from a practical point of view for compliance and Key Performance Indicators (KPIs). 

The European Medicines Agency (EMA) and the Pharmacovigilance Risk Assessment Committee (PRAC) deliberations and Brexit implications will be discussed.