Overview
This conference will focus on the differences between the present and new requirements for managing clinical trials in the face of forthcoming changes, including the new EU clinical trials Regulation but also conducting novel complex innovative design trials. Regulators and other decision-makers, together with various experts in the field, will debate how the new legislation will impact the processes for the design, submission and approval, and managing European clinical trials in the future.
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Program Committee
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Nick Sykes, MS Policy Advisor
EFPIA, Belgium -
Surendra Gokhale, DrSc, PhD Senior Director, Global Regulatory Affairs and Capability Development Lead
F. Hoffmann-La Roche Ltd, Switzerland -
Elke Stahl, PhD Senior Expert, Clinical Trials Department
Federal Institute For Drugs and Medical Devices (BfArM), Germany -
Rose-Marie Swallow Senior Manager, Policy & Research
Bayer Plc., United Kingdom -
Vladimir Vujovic, MPharm Director, Regulatory Affairs
IQVIA, Serbia
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