PHSR Students Visit FDA/CDER Office of Surveillance and Epidemiology

PHSR graduate students get inside look at regulatory agency and discuss post-marketing pharmacovigilance with OSE directors and epidemiologists

By Jingjing Qian
February 18, 2010

The University of Maryland School of Pharmacy’s International Society of Pharmacoepidemiology (ISPE) student chapter visited the Food and Drug Administration (FDA)/Center for Drug Evaluation and Research (CDER) Office of Surveillance and Epidemiology (OSE) in January for an inside look at the regulatory agency and to discuss post-marketing pharmacovigilance with OSE directors and epidemiologists.

FDA/CDER evaluates the safety profiles of drugs available to American consumers using a variety of tools and disciplines throughout the life cycle of the drugs. OSE uses information about adverse events through FDA’s MedWatch program, which together totals more than 250,000 reports each year, to identify drug safety concerns and recommend actions to improve product safety and protect the public health. Judy Staffa, associate director for regulatory research, provided an overview of OSE and its new structure under FDA/CDER. In addition, Solomon Iyasu, director of the Division of Epidemiology, gave a comprehensive overview of OSE’s important role in post-marketing surveillance and drug safety. Ann McMahon, deputy director of the Division of Pharmacovigilance I, emphasized the importance of proper education for better quality adverse event reports.

During the visit, the students had the opportunity to learn more about the role of safety evaluators under the FDA’s post-marketing pharmacovigilance, which is to identify and assess previously unrecognized (unlabeled), serious adverse events/safety signals over the post-marketing life cycle of a product.

In the end, students had an open discussion on drug safety issues with OSE epidemiologists.

“The experience not only helped us improve our knowledge of pharmacoepidemiology & pharmacovigilance but it also provided a deeper understanding of the FDA’s role in improving drug safety and protecting public health,” said Gaurav Deshpande, a fourth-year PHSR PhD student. “Moreover, it also served as a wonderful and necessary opportunity for students who are interested in the area of pharmacoepidemiology to build their networking channels.”

“It was an amazing opportunity for our graduate students to see inside a regulatory agency, and the students and I are extremely grateful for the experience,” said Sheila Weiss Smith, PhD, a professor of pharmaceutical health services research (PHSR) at the School of Pharmacy and director of its Center for Drug Safety who also serves as the faculty advisor for ISPE.

The ISPE student chapter was established by PHSR faculty and graduate students in the spring of 2008. Funding from the University of Maryland, Baltimore’s University Student Government Association and PHSR has helped ISPE student chapter organize several successful events on campus and at the International Conference on Pharmacoepidemiology & Therapeutic Risk Management.