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Digital Clinical Data Generation, Incorporation Into Regulatory Decision Making (Parkinson’s Disease, MS)
Session Chair(s)
Francesca Cerreta, PharmD, MPharm, MS
Principal Scientific Officer
European Medicines Agency, Netherlands
Manuel Haas, PharmD, MSc
Executive Director - Regulatory Affairs Europe
MSD UK, United Kingdom
CNS is a promising area to apply digital technologies to medicines’ development. Companies’ experience in designing studies and EMA’s in providing regulatory and scientific assistance, will be discussed.
Learning Objective : Illustrate the EMA experience in supporting development of digital technologies with CNS focus Define the challenges encountered in applying digital technologies to medicines development Design successful plans for regulatory interaction
Speaker(s)
Patient Perspective
Julian Isla, MS
Foundation 29, Spain
Director
Regulator Perspective
Marion Haberkamp, DrMed
BfArM, Germany
Head of Section Neurology, Psychiatry, Ophthalmology
Industry/Regulators Cooperation to Advance Digital Health Technology Development
Seya Colloud, PharmD
F. Hoffmann-La Roche Ltd, Switzerland
Global Regulatory Director
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