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New Ways to Learn What Happens to Patients AFTER Approval
Monday, June 25, 2012
10:00 AM to 11:30 AM
Steve received a PhD from MIT. He has held faculty appointments in electrical engineering at MIT, and in anesthesia and neurophysiology at Harvard Medical School and BWH. He founded Personal Health Technologies Corp. (PHT) in 1994 where serves as Chief Scientific Officer.
Donald Manning, Adynxx, Inc., United States
Dr. Gwaltney is currently Senior Scientist at PRO Consulting and Research Professor in the Department of Community Health at Brown University. He has provided expert advice regarding PROs to the pharmaceutical industry and National Institutes of Health across several therapeutic areas.
CDR Melissa Robb is the Project Director for FDA's Sentinel Initiative and works within CDER's Office of Medical Policy. She has experience in both premarketing and postmarketing evaluation of drugs and other FDA-regulated products.
This session explores new ways to help physicians monitor and support individual patients for whom they prescribe medications. A physician will present on the topic, and the chair is seeking discussion from attendees with medical experience.
Discuss shortcomings of pharmacovigilance, the limitations of tracking SAE's, REMS, and postmarket clinical research
Assess technologies and new ways to obtain information about a patient, and ways for physicians to support patient who use approved medications in the real world.
Audio Synchronized to PowerPoint