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 has been revised to bring together the current knowledge in seizures type and epilepsy. The revised guideline (revision 3) is under public consultation.

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 ongoing public consultation, the EMA workshop is an opportunity to bring together academia, industry, medicines regulators, healthcare professionals 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: Evidence needed to support extrapolation to monotherapy
• Session 2: Clinical development in epilepsy syndromes
• Session 3: Clinical development in paediatric population and extrapolation between age groups

Further information on the workshop programme will be published in due course.