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THE WAY FORWARD IN CNS: REGULATORY SCIENCE AT THE EDGE
Session Chair(s)
Barbara J Van Zwieten-Boot, PhD, FACP
Chairperson, Efficacy Working Party, CHMP, EMEA, EU
Medicines Evaluation Board, Netherlands
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
Speaker(s)
Biomarker Qualification Procedure
Violeta Stoyanova-Beninska, MD, PhD, MPH
Medicines Evaluation Board, Netherlands
Chair COMP EMA, Chair Scientific and Regulatory Advice MEB
Challenges in the Revised Guideline for Depression
Karl Broich, DrMed
Federal Institute for Drugs and Medical Devices (BfArM), Germany
President
Changes in the Field of Multiple Sclerosis
Andre J.A. Elferink, MD, PhD, MSc
CBG-MEB, Netherlands
Head Clinical Assessors
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