Regulatory Review and Approval Processes Under Current US Guidelines and Across the Globe
PowerPoint slides Brian Harvey
Start Date
4-21-2009 9:30 AM
End Date
4-21-2009 10:00 AM
Description
Brian E. Harvey, MD, PhD is Vice President, Regulatory Policy for sanofi-aventis, reporting to the global head of Regulatory Affairs. He leads the Corporate Regulatory Affairs (CRA) office in Bethesda, MD and interacts with the Food and Drug Administration (FDA), C-Path Institute and key industry representatives on behalf of sanofi-aventis. Dr. Harvey serves on the Pharmaceutical Research and Manufactures of America (PhRMA) Regulatory Affairs Coordination Committee (RACC), Asian Pacific Technical Committee and International Biologics and Biotechnology Taskforce/Biologics Key Issues Team. He is a member of the Biotechnology Industry Organization (BIO) Regulatory Affairs Committee (RAC).
Previously, Dr. Harvey worked for the FDA in the medical devices (CDRH), biologics (CBER) and drugs (CDER) centers. Most recently, he was the director of FDA’s Division of Gastroenterology Products. He was previously the Deputy Office Director for CDER’s Office of Drug Evaluation, having come to CDER from CBER in 2003. He started at FDA in 1995 as a medical officer in CDRH’s Gastroenterology and Renal Devices Branch. In 2000-2001, Dr. Harvey represented FDA as an American Political Science Association (APSA) Congressional Fellow, where he worked on health and scientific issues in the U.S. Senate.
Dr. Harvey graduated with honors from Middlebury College in Vermont. He completed his PhD in biochemistry, followed by his MD degree, at the University of Connecticut. He conducted post-doctoral research at Harvard Medical School and completed his internal medicine internship and residency at Boston’s Beth Israel Hospital. He completed a three-year gastroenterology fellowship at the Johns Hopkins Hospital. He continues to care for patients on weekends as a part-time hospitalist at Anne Arundel Medical Center in Annapolis, Maryland.
Regulatory Review and Approval Processes Under Current US Guidelines and Across the Globe
Brian E. Harvey, MD, PhD is Vice President, Regulatory Policy for sanofi-aventis, reporting to the global head of Regulatory Affairs. He leads the Corporate Regulatory Affairs (CRA) office in Bethesda, MD and interacts with the Food and Drug Administration (FDA), C-Path Institute and key industry representatives on behalf of sanofi-aventis. Dr. Harvey serves on the Pharmaceutical Research and Manufactures of America (PhRMA) Regulatory Affairs Coordination Committee (RACC), Asian Pacific Technical Committee and International Biologics and Biotechnology Taskforce/Biologics Key Issues Team. He is a member of the Biotechnology Industry Organization (BIO) Regulatory Affairs Committee (RAC).
Previously, Dr. Harvey worked for the FDA in the medical devices (CDRH), biologics (CBER) and drugs (CDER) centers. Most recently, he was the director of FDA’s Division of Gastroenterology Products. He was previously the Deputy Office Director for CDER’s Office of Drug Evaluation, having come to CDER from CBER in 2003. He started at FDA in 1995 as a medical officer in CDRH’s Gastroenterology and Renal Devices Branch. In 2000-2001, Dr. Harvey represented FDA as an American Political Science Association (APSA) Congressional Fellow, where he worked on health and scientific issues in the U.S. Senate.
Dr. Harvey graduated with honors from Middlebury College in Vermont. He completed his PhD in biochemistry, followed by his MD degree, at the University of Connecticut. He conducted post-doctoral research at Harvard Medical School and completed his internal medicine internship and residency at Boston’s Beth Israel Hospital. He completed a three-year gastroenterology fellowship at the Johns Hopkins Hospital. He continues to care for patients on weekends as a part-time hospitalist at Anne Arundel Medical Center in Annapolis, Maryland.
