The European Medicines Agency
The European Medicines Agency would like to let you know it is going to hold a Public Hearing on 26 September 2017.
The hearing is part of an ongoing review of valproate-containing medicines in the treatment of women or girls who are pregnant or of childbearing age.
This review (a so-called Article 31 referral) is being carried out by the Agency’s experts in medicines safety, the Pharmacovigilance Risk Assessment Committee (PRAC).
Those wishing to participate at the hearing, which will take place at the EMA offices in London, need to register in advance and may request to speak in front of the Committee or simply observe the proceedings. The hearing will also be broadcast live.
The public hearing will be based on several questions to which the PRAC is seeking the views of all stakeholders.
These questions and the safety issues of concern are published on the EMA website together with a guidance document, a video, and the application form.
The deadline for applications is 25 August 2017.
If you have any questions please contact the agency at: PublicHearings@ema.europa.eu