Meeting
Event Title
FDA Safety Report Type Flag Requirement for FAERS Submissions
February 19, 2021
Event Title
FDA Safety Report Type Flag Requirement for FAERS Submissions
February 19, 2021
- Date:
- February 19, 2021
- Time:
-
1:00 PM - 2:00 PM ET
Visit the CDER Small Business and Industry Assistance Webpage
FDA will introduce the FAERS FDA Safety Report Type Flag and communicate how to prepare for this new requirement.
TOPICS
- Discuss and define the FDA Safety Report Type Flag
- Highlight benefits associated with the requirement
- Communicate implementation considerations
AUDIENCE
Members of the pharmaceutical industry responsible for the submission of adverse event reports to the FDA.
FDA SPEAKERS
Suranjan De, MS, MBA
Deputy Director
Regulatory Science Staff (RSS)
Office of Surveillance and Epidemiology (OSE)
CDER | FDA
Nik Rementelas
Project Manager
Office of Business Informatics (OBI)
Office of Strategic Programs (OSP)
CDER | FDA
FDA RESOURCES – WEBTEAM PLS HYPERLINK
- FDA Webpage: FDA Adverse Event Reporting System (FAERS) Electronic Submissions
- Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments Technical Specifications Document