PRAC concludes evidence of potential risk of neurodevelopmental disorders in children born to men treated with valproate is inconsistent Committee recommends updating product…, Agenda Agenda of the PRAC meeting 8-11 June 2026Draft Reference Number: EMA/PRAC/115322/2026…, PRAC statistics: June 2026 , , Glossary Safety signal assessments. A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association between…