THE WAY FORWARD IN CNS: REGULATORY SCIENCE AT THE EDGE

Track:
Regulatory Science

Day & Time:
March 5, 11:00AM - 12:30PM

Session Number:
1402

Room Number:
G106

Type:
Session

Title:
THE WAY FORWARD IN CNS: REGULATORY SCIENCE AT THE EDGE

Chair(s):
Barbara J Van Zwieten-Boot, PhD,FACP
Chairperson, Efficacy Working Party, CHMP, EMEA, EU
Medicines Evaluation Board, Netherlands

Description:
In this session progress in the field of CNS (central nervous system) drug development is presented from a regulatory perspective, e.g. the usefulness of qualifying biomarkers for various purposes and the updating of regulatory guidelines

Presentation(s) & Speaker(s):
Biomarker Qualification Procedure
Violeta Stoyanova, MD,PhD,MPH
COMP Member, Senior Clinical Assessor
Medicines Evaluation Board, Netherlands

Challenges in the Revised Guideline for Depression
Karl Broich, DrMed
Vice President
Federal Institute for Drugs and Medical Devices (BfArM), Germany

Changes in the Field of Multiple Sclerosis
Andre J.A. Elferink, MD,PhD,MSc
Head Clinical Assessors
CBG-MEB, Netherlands