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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
Speaker(s)
Elke Stahl, PhD
Senior Expert, Clinical Trials Department
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
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