|Project Title||International Regulator’s Forum - Day 3 of the Eleventh Annual Sentinel Initiative Public Workshop|
Friday, April 5, 2019
The U.S. Food and Drug Administration (FDA) will be hosting a forum on April 5, 2019 on the Sentinel System for other regulatory agencies immediately following the two-day Sentinel Annual Meeting. This training was developed in response to requests for further information on how FDA operationalizes Sentinel to meet its legislative mandate in the FDA Amendments Act 2007 and other key legislative commitments. Day 3 is by invitation only for international regulators.
Agenda and Details: This is a forum designed for staff from regulatory agencies worldwide: it is a meeting by regulators, for fellow regulators. The intent is to create a full three-day intensive experience on Sentinel where participants would attend Day 1 and Day 2 of the Sentinel Annual Meeting to understand the current state of the system and obtain technical training, and then attend the International Regulator’s Forum on Day 3. The aim of Day 3 is to provide a dedicated time and place for all regulators to learn about how FDA operationalizes and implements the Sentinel System to inform regulatory decision making. The training will address procedural and policy topics starting from the process for how FDA determines when to use the capabilities in the Active Risk Identification and Analysis (ARIA) system, to the development of safety analyses, and communication of results.
Registration and location information are available here.
- Vaccines, Blood & Biologics
- Devices and Radiologic Health