Eleventh Annual Sentinel Initiative Public Workshop


Public Workshop

Eleventh Annual Sentinel Initiative Public Workshop

April 3, 2019 — 9:00AM–4:30PM

Contact Information

Sarah Supsiri


The Sentinel Initiative was launched in response to the Food and Drug Administration Amendments Act of 2007 (FDAAA) and is comprised of several components including the Sentinel System, the Active Risk Identification and Analysis System, the Biologics Effectiveness and Safety System (BEST IDIQ #1BEST IDIQ #2) and FDA Catalyst. The Food and Drug Administration (FDA) is committed to facilitating stakeholder engagement on approaches to modernize the Sentinel Initiative’s capabilities.

The annual public workshop is a gathering of the Sentinel community and leading experts to share recent developments within the Sentinel Initiative, to provide training on the Sentinel System’s tools and data infrastructure, and to promote engagement and collaboration with patients, industry, academia, and consumers. This year marks the Eleventh Annual Sentinel Initiative Public Workshop and will be a two-day event. 

To improve access to important workshop information across both days a new mobile application tool will be available at this year’s workshop. The Guidebook mobile application will make all workshop content accessible on your mobile device, including agendas and speaker bios. We encourage you to download the application from the Sentinel Annual Meeting Guidebook page ahead of the workshop.


DAY 1 | Sentinel Initiative Public Workshop, April 3, 2019

Registration: Open to everyone. Please register through this Duke-Margolis link.

Location: Hyatt Regency Bethesda, 1 Bethesda Metro Center, Bethesda, MD 20814

Agenda and Details: Day 1 will be convened by the Robert J. Margolis, MD, Center for Health Policy at Duke University under a cooperative agreement with FDA. The workshop will feature updates on how the Sentinel Initiative is being used by FDA as a core safety surveillance program from leaders at FDA and from investigators within the Sentinel Initiative. Discussion will also highlight strategic initiatives and potential future directions for continued improvements to the distributed data infrastructure. There will be opportunities throughout the day’s discussion for stakeholders to provide input and ask questions.

A meeting agenda will be posted in advance of the workshop. The webcast for this event will be found on the Duke-Margolis event website and will go live once the workshop begins. 


DAY 2 | Sentinel System Analysis Tools Training: Hands-On Workshop, April 4, 2019

Registration: Open to everyone. Please register through this Day 2 link.

Location: FDA White Oak Campus, 10903 New Hampshire Avenue, Building 31, Room 1503 A (the Great Room), Silver Spring, MD 20993

Agenda and Details: Day 2 will be the third public training sponsored by FDA and the Sentinel Operations Center targeting researchers who have prior experience executing epidemiologic analyses with claims data using SAS statistical packages and programming. Registrants are expected to have either attended the prior Sentinel Public Training Events held in July 2017 (Part 1) and February 2018 (Part 2) or viewed the recorded contents online prior to attending.

This workshop will build on these prior trainings using a hands-on laboratory format. Attendees should bring a laptop to the training to participate. Due to the interactive nature of the training, no online participation will be available.

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.