SME info day on the new clinical trial regulation

• Date:
  Monday, 20 March 2017, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

This SME info day provides an overview on the key features and objectives of the new clinical trial regulation. It also covers the future clinical trial authorisation process, the functionalities of the EU CT portal and database, transparency aspects of the new regulation and safety reporting requirements. The event is for companies that have been assigned SME status by the EMA and representatives of stakeholder organisations.

Documents

Agenda - SME info day on the new clinical trial regulation

Adopted Reference Number: EMA/816344/2016

Presentation - An SME perspective on the implementation of the EU Clinical Trials Regulation (Kate Darwin)

Presentation - The new submission process (Tomas Boran)

Presentation - EU CT portal and database (Noemie Manent)

Presentation - Future Training Programme (Ana Rodriguez)

Presentation - Key features and objectives of Regulation EU No. 536/2014 (Laura Pioppo)

Presentation - Clinical trial safety reporting requirements (Sophia Mylona)

Presentation - The future clinical trial authorisation process: the new evaluation process (Massimiliano Sarra)

Presentation - What is new in terms of transparency (Kevin Cunningham)

Multimedia