First information day on periodic safety update reports (PSURs) – International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) E2C(R2) periodic benefit-risk evaluation reports

• Date:
  Wednesday, 19 June 2013, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

This information day provides a forum to hear the latest news from regulators running the assessment process and pharmaceutical-industry experts from the ICH E2C Expert Working Group. The discussion will focus on how to ensure the high quality of PSURs and assessment for public health, and on the greater emphasis on meaningful evaluation of important new risk information in the context of a medicine's benefits. Places limited.

Documents

Agenda and registration form - First information day on periodic safety update reports – International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use E2C(R2) perio...