The Pharmacovigilance Risk Assessment Committee (PRAC) held their monthly meeting on 25-29 September 2017 and have since published the highlights on the EMA website.
This meeting also doubled up as a public hearing which is a first for the PRAC. The public hearing focused on the safety of valproate and related substances in women and girls who are pregnant or of child-bearing age as part of their continued evaluation. There were 84 citizens who joined the hearing as well as 25 speaker contributions. Following the hearing, PRAC will discuss and appraise the comments and suggestions received by the speakers and reflect on these will assessing the safety of valproate.
To find out more about the PRAC public hearing or to read the highlights from the monthly meeting, please click here.