Regulations for Clinical Studies in Pediatric Patients in the European Union
After the United States issued pediatric drug study requirements, the European Union (EU) passed a regulation that created major changes to clinical studies for pediatric patients. A significant step toward safer dosing for children, the EU guidance opens new questions about pediatric drug development. Quintiles regulatory experts Dr. Raj Kishore and Dr. Edward Tabor review the major provisions of the EU regulation and compare it to its US counterpart. Of particular interest: Exclusivity incentives for conducting studies in pediatric patients, including orphan indications.
About the Authors
Raj Kishore, PhD Regulatory Strategy
Dr. Kishore brings over 23 years of experience in regulatory affairs, including 10 years at the FDA in the Office of Generic Drugs and 11 years in multinational pharmaceutical companies including Otsuka, Shire and EMD. At each of these firms, he served as primary contact with the FDA on all his projects. His therapeutic areas of experience include oncology, neurology and cardiovascular indications.
He received his PhD in nuclear chemistry from Clark University in Worcester, MA, and was a postdoctoral fellow at the University of California, Irvine, at Brookhaven National Laboratory and at Harvard Medical School. He spent 12 years at the Albany VA Hospital as the Director of the radioimmunoassay laboratory and Associate Professor at Albany Medical College. He was also a visiting scientist at the University of Washington, Seattle.
Edward Tabor, MD Vice President, Head of Global Regulatory Strategy
Dr. Tabor heads up our work in regulatory strategy, drawing on years of experience with the FDA. He joined Quintiles after serving as Associate Director for Medical Affairs in the Office of Blood Research and Review at the FDA. He was also a Division Director in the FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation & Research (CBER). Here he led the review and approval of products including the first treatment for human immunodeficiency virus. He also led the development of the antiviral regulatory policy and created an antiviral review group that formed the basis of the FDA’s Division of Antiviral Drug Products. Dr. Tabor also participated in the development of many FDA policies and policy documents. In addition, he managed an active laboratory-based research program.
At the National Institutes of Health (NIH), he was Associate Director for Biological Carcinogenesis for the National Cancer Institute, supervising six large intramural research laboratories. Dr. Tabor is an internationally known expert on hepatitis viruses and liver cancer. He is an author of more than 300 publications on viral hepatitis and other infections transmitted by blood transfusion, has written or edited six scientific books, and holds seven US patents (on behalf of the US government).
Dr. Tabor earned his undergraduate degree from Harvard University and his MD from Columbia University, where he did a residency in pediatrics at Columbia-Presbyterian Medical Center.
