Clinical Trial Regulation Conference

This conference provides a forum for information exchange and discussion on conceptual and practical questions about critical issues affecting sponsors and Member States regarding the implemention the regulation.

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SESSION 5: SAFETY REPORTING IN THE EU CLINICAL TRIAL REGULATION- AN UPDATE ON DEVELOPMENTS AND INTERACTIVE Q&A SESSION

Session Chair(s)

Esteban Herrero-Martinez, PhD

Director Regulatory Policy and Intelligence

AbbVie, United Kingdom

Interactive question and answer session between industry and regulators (CTFG rep and EMA rep) to discuss recent developments, outstanding issues and current thinking on clinical trial safety reporting

Speaker(s)

Elke Stahl, PhD

Federal Institute For Drugs and Medical Devices (BfArM), Germany

Senior Expert, Clinical Trials Department

Amanda Joseph

Eli Lilly and Company, United Kingdom

EU Advisor, Clinical Case Management

Camelia Mihaescu

European Medicines Agency, Netherlands

GCP, GLP and PhV Inspections

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