Epilepsy Ireland News

14|07|2017| Sodium valproate public hearing looking for victims across Europe

14 July 2017
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A public hearing is to be held in London on September 26th 2017 to listen to the experiences of women in the EU who have been prescribed valproate-containing medicines for epilepsy, bipolar disorders and migraine. The deadline for applications to attend as a speaker or observer is August 25th 2017.

This will be the first time the European Medicine Agency's safety committee - the Pharmacovigilance Risk Assessment Committee (PRAC) - has held a public hearing to review safety review of a medicine.

The public hearing will focus on three questions:

  • What is your view of the risks of taking valproate during pregnancy, including its potential effect on the child?
  • What are your views on the measures currently in place to reduce the risks of using valproate during pregnancy?
  • What other measures should be taken to reduce the risks of using valproate during pregnancy?

Anyone wishing to take part in the hearing, either as a speaker or an observer, can now submit an application at the European Medicines Agency's website. Application forms should be completed at the link above and returned to hearings@ema.europa.eu. All applicants will be notified within two weeks of the deadline as to whether they have been selected to attend.

The meeting will take place in EMA's London offices in Canary Wharf on August 25th.

Article source: Epilepsy Society.

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