Session 10 – Epidemiology

Day & Time:
January 16, 10:30AM - 12:00PM

Type:
Session

Title:
Session 10 – Epidemiology

Chair(s):
Mariette Boerstoel-Streefland, MD,MBA,MS
Chief Safety Officer, Vice President-Global Drug Safety
Forest Research Institute, United States

Description:
Session 10 – Epidemiology

Presentation(s) & Speaker(s):
Opportunities and Challenges Associated with the Use of Existing Automated Databases in the Assessment of Drug Safety
Jesse A. Berlin, DrSc
Vice President, Epidemiology
Janssen Research & Development LLC, United States

Role of Observational Data in Regulatory Decision Making: The Drug Safety Paradigm
Tarek A Hammad, MD,PhD,MS
Deputy Director
FDA, United States