Personal Reflections on Global Clinical Trials
Please join us as Mathew T. Thomas, MD, Health Science Administrator at the Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD), gives a brief overview of the FDA’s Bioresearch Monitoring Program, with an emphasis on outcomes of the FDA’s international clinical inspections.
Dr. Thomas will also share his personal reflections on the advantages and challenges of conducting clinical trials around the world. This presentation will be based on Dr. Thomas' experience as a reviewer in the Division of Scientific Investigations within the Center for Drug Evaluation and Research, where he participated in about 39 international clinical inspections in 15 countries over a 12-year period.
Dr. Thomas is a Health Science Administrator in the FDA Office of Orphan Products Development (OOPD) and is responsible for coordinating OOPD’s outreach activities, reviewing requests for orphan product designation, and managing several OOPD grants. Dr. Thomas has worked for the FDA since 1989. He joined the FDA’s Center for Drug Evaluation and Research (CDER) as a medical reviewer in the Division of Metabolism and Endocrine Drug Products, and then worked as a reviewer in the Division of Scientific Investigations (DSI) for 12 years before joining OOPD. In 2009, Dr. Thomas served as the Chair of the FDA’s Research in Human Subjects Committee (FDA’s IRB).
Dr. Thomas completed his medical education at the University of Madras in India, followed by a Fellowship in Lipid Disorders at the Medical College of Pennsylvania, Philadelphia, and a Fellowship in Clinical Pharmacology and Regulatory Sciences at the FDA and Georgetown University in Washington DC. He also earned a Certification in Public Health from Georgetown University.
Please RSVP for this event at http://mathewthomas102510.eventbrite.com.
Light refreshments will be served.
|Where:||KGI Main Campus, Building 517, Lecture Hall|
|When:||October 25, 2010, 5:30 p.m. - 6:30 p.m.|