Pharmacovigilance and Risk Management Strategies 2015

Gerald Dal Pan, MD, MHS

Director, Office of Surveillance and Epidemiology, CDER

Updates from the FDA/Office of Surveillance and Epidemiology

Gerald Dal Pan, MD, MHS

FDA, United States

Director, Office of Surveillance and Epidemiology, CDER

Using Drug Target Adverse Event Profiles to Predict and Analyze Safety Signals

Keith K. Burkhart, MD

FDA, United States

Senior Advisor for Medical Toxicology, DARS, OCP, OTS

Pharmacological Mechanism-Based Approaches for Signal Strengthening/Weakening for Potential Safety Signals

Darrell R. Abernethy, MD, PhD

FDA, United States

Associate Director for Drug Safety, Office of Clinical Pharmacology, CDER