Twelfth Annual Sentinel Initiative Public Workshop

April 20, 2020 - 9:00 am to April 21, 2020 - 4:45 pm

10 Thomas Circle

Washington, DC 20005

margolisevents@duke.edu

Description

The Sentinel Initiative, an active medical product surveillance system, was established in response to the Food and Drug Administration (FDA) Amendments Act of 2007 and has become one of the Agency’s premier evidence generation platforms. The 12th Annual Sentinel Initiative Public Workshop is being convened on April 20-21, 2020 by the Robert J. Margolis, MD, Center for Health Policy under a cooperative agreement with the FDA. The two-day workshop will be held at the Washington Plaza Hotel in Washington, DC and provides an opportunity to discuss recent achievements and engage with the broader community of patients, consumers, and scientific stakeholders.

MEETING AGENDA AND MATERIALS

The agenda, speaker bios and meeting materials can be accessed using a mobile application called Guidebook that is available for iOS and Android platforms. Attendees are encouraged to download the application.

DAY 1, Sentinel Annual Public Workshop, April 20, 2020

Featuring a keynote by Dr. Patrizia Cavazzoni from FDA and numerous expert panelists who will provide updates on major system developments, milestones, and strategic aims.

DAY 2, Innovation Day and Sentinel System Public Training, April 21, 2020

Featuring a morning session with presentations from key leadership and experts from the new Sentinel Innovation Center, followed by an afternoon session consisting of didactic training on the new capabilities in maternal health and pregnancy in Sentinel, including the new mother-infant data linkage.

Meeting materials will be posted on this event web page in advance of the workshop. The webcast for Day 1 and Day 2 will go live once the workshops begins. If you have any questions or concerns, please email margolisevents@duke.edu.

Funding for this conference was made possible by a cooperative agreement from the Food and Drug Administration, Center for Drug Evaluation Research. The views expressed in written conference materials and the speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services, nor does mention of trade names, commercial practices, or organizations imply endorsements by the U.S. Government.