Multi-stakeholder workshop on the guideline on clinical investigation of medicinal products in the treatment of epileptic disorders
Event
Human
Medicines
Date
- Monday, 29 January 2024, All day
Location
- Online
Event summary
The EMA is organising an online multi-stakeholder workshop on the revised guideline on clinical investigation of medicinal products in the treatment of epileptic disorders.
The guideline on clinical investigation of medicinal products in the treatment of epileptic disorders has been revised to bring together the current knowledge in seizures type and epilepsy. The new revised guideline (revision 3) is under public consultation until 30 January 2024.
The intention of the revised guideline is to provide general guidance on the development of medicinal products for the treatment of epileptic disorders, to support evidence generation, to enable appropriate methodology for the evaluation of medicinal product for the treatment of epileptic disorders and to further inform regulatory decision making.
As part of the on-going public consultation, the EMA workshop is an opportunity to bring together medicines regulators, healthcare professional, academia, industry and patients’ representatives to discuss clinical and scientific aspects of the development of medicinal products in the treatment of epileptic disorders, and to share the clinical knowledge and the science in the development of anti-seizure medications with the objective to allow an efficient and robust regulatory assessment.
The workshop will be structured with 3 sessions:
- Session 1: Clinical development in epilepsy syndromes
- Session 2: Clinical development in paediatric population and extrapolation between age groups
- Session 3: Evidence needed to support extrapolation to monotherapy