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Regulatory Sandbox
Session Chair(s)
Francois Hebraud, PharmD
EU Regulatory Policy Lead
Roche, Switzerland
Falk Ehmann, MD, PhD, MS
Head of Innovation and Development Accelerator
Regulatory Science and Innovation Task Force, European Medicines Agency, Netherlands
Regulatory Sandbox
Learning Objective : Participants will get a better understanding of the mechanism, conditions to ensure its effectiveness and sustainability and its place within the reg toolbox, including perspectives and opinions on the opportunities and challenges from legislators, regulators, industry and potentially other stakeholders.
Speaker(s)
Regulatory Sandbox - Is Europe Ready to Take Full Advantage of This Adaptive Tool?
Francois Hebraud, PharmD
Roche, Switzerland
EU Regulatory Policy Lead
Understanding the Sandbox Concept for Exploration of New Approaches
Falk Ehmann, MD, PhD, MS
Regulatory Science and Innovation Task Force, European Medicines Agency, Netherlands
Head of Innovation and Development Accelerator
The Industry Perspective
Lamine Messaoudi, DVM, MS
Takeda Pharmaceuticals International Gmbh, Switzerland
Head Of EUCAN Regulatory Policy And Innovation
Panelist
Julie Spony, MA
European Patients' Forum, Belgium
Policy Officer
Johanne Veenstra
Health Canada, Canada
A/Drug GMP Specialist,