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How to Ensure Compliance in a Changing Regulatory Environment: A Regulators Perspective
Session Chair(s)
Jennifer Emerson, PhD, MPH, RN, PMP
Head Quality Analytics & Risk Management
Boehringer Ingelheim, Germany
Hear the thoughts of regulators regarding how they see the future direction of travel for GCP Inspections. Learn about changes to compliance strategies and collaboration initiatives which are underway or in the pipeline.
Learning Objective : Describe challenges currently faced by regulators regarding clinical trial inspections; Discuss strategies being developed by Health Authorities including future initiatives, direction of travel, and collaborative relationships.
Speaker(s)
FDA Update
Emily Gebbia, JD
FDA, United States
Associate Director for Regulatory Development, OSI, OC, CDER
Panelist
Junko Sato, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Associate Executive Director
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