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GCP Findings and the Benefit-Risk Balance
Session Chair(s)
Jens Heisterberg, MD
Vice President, Regulatory Intelligence
Novo Nordisk, Denmark
GCP Findings and the Benefit-Risk Balance
Speaker(s)
When Things Go Wrong: How Do GCP Findings Impact the Benefit-Risk Balance? Can We Still Use the Data?
Nancy Breekveldt-Postma, PhD
Medicines Evaluation Board, Netherlands
Senior Clinical Assessor
Clinical Development/Operations Staff and GCP Auditors – Are We Aligned? Industry Perspective
Liliana Hansen, MD
Novo Nordisk A/S, Denmark
Director Safety Surveillance Insulin & Devices Global Safety
Clinical Assessors and GCP Inspectors: Different roles – Can the Interface be Optimised? Case Examples and Agency Perspective
Gabriele Schwarz, MPharm
Federal Institute for Drugs and Medical Devices (BfArM), Germany
GCP Strategy Expert
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