29th Annual EuroMeeting

The EuroMeeting provides experts from all disciplines of healthcare product development a platform to debate and find solutions to the challenges of an ever-evolving healthcare system.

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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

Germany

EC ICH E6(R3) Expert Working Group Member

29th Annual EuroMeeting

GCP Findings and the Benefit-Risk Balance

Session Chair(s)

Jens Heisterberg, MD

Speaker(s)

When Things Go Wrong: How Do GCP Findings Impact the Benefit-Risk Balance? Can We Still Use the Data?

Clinical Development/Operations Staff and GCP Auditors – Are We Aligned? Industry Perspective

Clinical Assessors and GCP Inspectors: Different roles – Can the Interface be Optimised? Case Examples and Agency Perspective

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