Gerald J. Dal Pan, MD, MHS currently serves as the Director of the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research, where since 2005 he has been responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. In this capacity, he is involved in both the premarket and postmarket regulation of drugs and therapeutic biologics, and in the implementation of the drug safety provisions of the Food and Drug Administration Amendments Act and other initiatives. He is also a member of the World Health Organization Advisory Committee on the Safety of Medicinal Products and has served on the Council of International Organization of Medical Sciences (CIOMS) Working Groups VI (Management of Safety Information from Clinical Trials), VIII (Practical Aspects of Signal Detection in Pharmacovigilance), and IX (Medicinal Product Risk Management). He was a member of the International Conference on Harmonization (ICH) Expert Working Group E2C (R2), which developed the ICH guideline on the Periodic Benefit-Risk Evaluation Report. Gerald received his MD at Columbia University College of Physicians and Surgeons and his Master of Health Science in Clinical Epidemiology at the Johns Hopkins University School of Hygiene and Public Health. He completed residency training in Internal Medicine at the Hospital of the University of Pennsylvania and in Neurology at the Johns Hopkins Hospital. He is board certified in both Internal Medicine and Neurology. Gerald joined FDA in 2000 as a medical reviewer in the Center’s Office of New Drugs; in 2003 he became a division director in the Office of Drug Safety, the predecessor office to the Office of Surveillance and Epidemiology. Before working at FDA, Gerald was a faculty member in the Department of Neurology at Johns Hopkins and worked in the pharmaceutical industry.