June 2017 – The Pharmacovigilance Risk Assessment Committee (PRAC) has set a date for a public hearing

June 2017

The Pharmacovigilance Risk Assessment Committee (PRAC) has set a date for a public hearing on the use of Valproate.

The PRAC decided it will hold its very first public hearing on 26 September 2017 at the Agency’s premises in London. They will discuss the safety review of the use of valproate-containing medicines in the treatment of women and girls who are pregnant or of childbearing age. EU citizens will be invited to share their experiences with these medicines so that this can be taken into account in the Committee’s recommendation.

PRAC plans to issue further information at the beginning of July.

This is the first time the PRAC will hold a public hearing during a safety review of a medicine. It follows the adoption of rules of procedure on the organisation and conduct of public hearings and a simulation training in 2016.

The FACS Forum welcomes this news and we plan to be represented at the public hearing.

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/06/news_detail_002761.jsp&mid=WC0b01ac058004d5c1

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