Public hearing into sodium valproate - your chance to take part
Public hearing into sodium valproate to be held on 26 September 2017
Closing date for applications to attend as a speaker or observer is 25 August 2017
The hearing will be held at the EMA's London offices in Canary Wharf
Results will be presented to a public hearing held on 26 September 2017 to listen to the experiences of women in the EU who have been prescribed valproate-containing medicines1 for epilepsy, bipolar disorders and migraine.
Risks around sodium valproate
For some women with serious conditions, valproate may be the best or only treatment option. However, it has long been known that, if taken during pregnancy, it can affect the unborn baby and cause certain abnormalities.
The European Medicines Agency (EMA) has already strengthened warnings and restrictions on the use of valproate in women and girls due to the risk of malformations and developmental problems in babies who are exposed to valproate in the womb.
However concerns have been raised about how effective these measures are and the EMA has been asked to consider whether further EU-wide action should be recommended to minimise risks for women who are pregnant or of childbearing age.
First ever public hearing as part of safety review of a drug
This will be the first time the EMA's safety committee - the Pharmacovigilance Risk Assessment Committee (PRAC) - has held a public hearing as part of a safety review of a medicine.
The public hearing will be held at the EMA's London offices in Canary Wharf and 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. The closing date for applications is 25 August 2017. Application forms should be completed at the link above and returned to email@example.com All applicants will be notified within two weeks of the deadline as to whether they have been selected to attend.
On the EMA's website you will find:
- A summary of safety concerns and full list of questions for the public hearing on valproate
- Guidance for participants in public hearings
- A information video about public hearings
- Application form to attend the public hearing.
Applicants are asked to give details of their own experience of valproate in no more than 3000 characters and to say how long they would like to speak for (5- 10 minutes is usually recommended for each speaker). If you are not selected to make a presentation at the hearing, you can still submit a written statement to firstname.lastname@example.org which will feed into the review in the same way as presentations at the hearing. If you would like to make a presentation but are unable to attend, you wmay be able to participate via teleconference.
The hearing will be broadcast live on 26 September at the European Medicines Agency website at www.ema.europa.eu/ema
1 Marketed under the trade names: Absenor, Convival Chrono, Convulex, Delepsine, Depakin, Depakine, Depakote, Depamag, Depamide, Deprakine, Diplexil, Dipromal, Epilim, Episenta, Epival, Ergenyl, Espa-Valept, Hexaquin, Kentlim, Leptilan, Micropakine L.P., Orfiril, Petilin, Valepil, Valhel PR, Valpal, Valpro and Valprolek