Valproate In The Spotlight As EMA Releases Date For First Ever Public Hearing
The European Medicines Agency has released the date for its public hearing on valproate in which EU citizens will for the first time be given a voice in evaluating the safety of medicines on the market.
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The first ever public hearing on the safety of marketed medicines being organized by the European Medicines Agency has drawn a “very positive” response from the members of the public who have applied to attend the event on Sept. 26. The agency is now shortlisting an appropriate mix of speakers and observers.
The European Medicines Agency has yet to use the power it has to hold public hearings on marketed medicines that raise safety concerns. It says it will do so only when the time is right.
In the course of its mandate to help companies carry out joint post-authorization safety studies under the EU pharmacovigilance legislation, the European Medicines Agency is planning to organize a teleconference/webinar for a new study concerning the anti-epileptic drug valproate so that interested companies may be introduced to each other and have the opportunity to interact and raise questions.