15 April 2016 - PRAC adopts rules of procedure on public hearings on selected safety reviews.

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has adopted the final rules of procedure for public hearings to be held by the Committee. The rules of procedure describe the process and practical arrangements for the preparation, conduct and follow-up of public hearings.

As part of the implementation of these rules, the EMA will now organise an internal dry run exercise in order to test the process and procedures of public hearings. The dry run is scheduled to take place at the PRAC meeting in July 2016. Public hearings could take place as early as the fourth quarter of 2016, as soon as a relevant topic is identified.

For more details, go to: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/04/news_detail_002512.jsp&mid=WC0b01ac058004d5c1