Public hearing on Valproate

PUBLIC HEARING ON THE USE OF VALPROATE IN MIGRAINE DURING PREGNANCY OR CHILDBEARING AGE AT EUROPEAN MEDICINES AGENCY, LONDON, 26 SEPTEMBER 2017

The European Medicines Agency (EMA) is inviting citizens to share their experience with valproate – a medicine that treats epilepsy, bipolar disorder and migraine – at its very first public hearing on 26 September 2017 at the Agency’s offices in London.

The public hearing is part of a review by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) that looks at the safety of using valproate-containing medicines in women and girls who are pregnant or of childbearing age. There is a risk of malformations and neurodevelopmental problems in babies who are exposed to valproate in the womb, and the review follows concerns that EU-wide risk minimisation measures currently in place do not seem to be sufficiently effective.

EU citizens are invited to share their experiences with these medicines, so that these can be heard before the committee’s recommendation. 

The PRAC is seeking input from the public on a list of specific questions. These are set out in the document below, together with a summary of the safety concerns with this medicine:

Summary of safety concerns and list of questions for the public hearing on valproate

If you are considering taking part, please read the full guidance on how to participate:

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Public hearings – guidance for participants

The guidance describes the process and practical arrangements for public hearings, including how to participate either as a speaker or an observer.

EMA has also made an   information video.
To register your interest in taking part, please complete and return the application form to publichearings@ema.europa.eu EMA by 25 August 2017:

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Application form to attend the public hearing on valproate on 26 September 2017

EMA will write to all applicants within two weeks after the application deadline to confirm whether they can attend.

The hearing will also be broadcast live on 26 September 2017 on EMA’s website.

For more information about public hearings at EMA, see Public hearings.

For more information on the PRAC meeting where the public hearing will take place, see: PRAC: 25-28 September 2017.