Information day on risk management planning and post-authorisation studies

• Date:
  Monday, 7 November 2016, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

The European Medicines Agency (EMA) has proposed significant changes to the European Union (EU) pharmacovigilance guideline on risk management plans (GVP Module V). This information day will aim to explain marketing authorisation holders and applicants the changes, using practical examples. The information day will also look into the topic of post-authorisation safety studies (PASS), providing an insight into current activities and lesson learned from EMA committees. The guideline on PASS has set up the procedure for requiring PASS whenever there are concerns about the risks of an authorised medicine. In addition, the event will include a session on EMA progress in engaging patients and the public in medicines safety.

Documents

Agenda and registration form - Information day on risk management planning and post-authorisation studies