For Health Professionals
FDA 2nd Annual Health Professional Organizations Conference
October, 4, 2012 at the FDA White Oak Campus, in Silver Spring, MD.
The U.S. Food and Drug Administration Office of Special Health Issues (OSHI), Health Professional Liaison Program will be hosting its' second annual Health Professional Organizations Conference in collaboration with the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH) on Thursday, October 4, 2012 at White Oak. OSHI is responsible for creating and maintaining relationships with health professional organizations to improve communications between their members and the FDA.
The aim of the conference is to further the public health mission of the FDA through training, collaboration, and structured discussion between health professional organizations and FDA staff.
The meeting includes a series of presentations, break out sessions, and panel discussions to facilitate a dialogue with the health professional organizations.
Please include the name and title of the person attending, the name of the organization, e-mail address, and telephone number. There is no registration fee for this conference. Early registration is suggested because space is limited. If you need special accommodations due to a disability, please contact the Office of Special Health Issues at 301-796-8460 at least 7 days in advance of the conference.
The following is a tentative agenda and is subject to change:
8:30 – 9:00 AM - Registration
9:00 – 9:20 AM - Welcome
FDA’s Health Professional Liaison Program
Heidi C. Marchand, PharmD
Assistant Commissioner, Office of Special Health Issues
9:20 – 10:20 AM - FDA Safety and Innovation Act Update
Assistant Commissioner, Office of Legislation
10:20 - 10:40 AM - Break (Exhibit Tables)
10:45 – 11:45 AM - Public/Private Partnerships, FDA-CDRH Network of Experts
Michelle McMurray-Heath, MD, PhD
Associate Director for Science, CDRH
American Colleges of Cardiology, Lisa Goldstein and
The Society of Thoracic Surgeons, Philip Bongiorno
Perspective on FDA Network of Experts Program
11:45 – 12:00 PM - Introduction of speakers and topics for afternoon breakout sessions
12:00 - 1:00 PM - Break for Lunch (On your own. Boxed lunches will be available for purchase.)
1:10 - 3:30 pm - AFTERNOON BREAKOUT SESSION TOPICS
The format may consist of a short presentation followed by an open discussion
- Speed Networking with FDA
- MedWatch: Why Every Report is Important
- FDA.gov-Usability and Content Discussion
- Where can I get timely information to give to my patients?
- Protecting Patients from Counterfeit and Other Substandard Drugs/Supply Chain Threats
- Collaborating with professional associations to increase awareness about serious drug risks and risk evaluation and mitigation strategies (REMS)
- Advisory Committee nomination process for Health Professional Organizations
- NSURE (Non-prescription Safe-Use Regulatory Expansion) initiative
3:30 - 3:45 PM - Recap of the day
3:45 - 4:00 PM - Closing Remarks
Dr. Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs