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Session Chair(s)
Sylvie Tomczyk, MD, PHD
Senior Medical Director
EMD Serono, United States
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