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Session 2: Post Marketing Safety Requirements: US and EU
Session Chair(s)
Sylvie Tomczyk, MD, PhD
Senior Medical Director
EMD Serono, United States
This session will describe the reporting requirements for marketed drugs in the US and the EU region, for individual and aggregate safety reports. This will help understanding the key obligations and key differences between these two regions, and yet the common goal towards updated, accurate safety information.
Speaker(s)
MedWatch from Spontaneous Report to FDA Alert and Beyond: An Overview of Incorporating Safety Information into Practice
Heidi Marchand, PharmD
Gilead Sciences, United States
Executive Director and Head of Global Regulatory Policy and Intelligence
Post Marketing Requirements (not requiems) EU amd US for Individudal Case Safety Reports
Sylvie Tomczyk, MD, PhD
EMD Serono, United States
Senior Medical Director
Signal Management and Aggregate Safety Information Reporting with CoBRA(R), Best Practices According to EU/GVP Regulations
Susanne Ramm, DrMed
Dr. Ebeling & Assoc. Gmbh, Germany
Medical Director
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