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.

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 Ltd, 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

• CTFG Co-Chair; Clinical Trial Unit
• Federal Institute For Drugs and Medical Devices (BfArM), Germany

Amanda Joseph

• EU Advisor, Clinical Case Management
• Eli Lilly and Company, United Kingdom

Camelia Mihaescu

• GCP, GLP and PhV Inspections
• European Medicines Agency, Netherlands