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The Food and Drug Administration (FDA) is re-announcing three public meetings entitled “Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards.” The purpose of these public meetings is to provide the pharmaceutical industry and other interested parties with information on the plans, progress, and technical specifications to upgrade electronic submission standards for the premarket and postmarket safety surveillance programs managed by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). These meetings will focus on enhancements to electronic submission of Individual Case Safety Reports (ICSRs) in FAERS using ICH E2B(R3) standards.

Dates and Times:

March 25, 2019, from 9:00 a.m. – 4:00 p.m. 
July 17, 2019, from 9:00 a.m. – 4:00 p.m.
February 19, 2020, from 9:00 a.m. - 4:00 p.m.

Location:

For March 25, 2019 meeting:
Silver Spring Civic Building at Veterans Plaza
The Buffalo Soldiers Great Hall
One Veterans Place
Silver Spring, MD 20910

*Please enter the building from the Plaza side
GPS Device Address: 8525 Fenton Street, Silver Spring, MD 20910

For July 17, 2019 and February 19, 2020 meetings:
FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31 Conference Center, the Great Room (Rm. 1503, Section A)
Silver Spring, MD 20993-0002

Meeting Materials

• Federal Register Notice

February 19, 2020 meeting:

• Agenda (PDF - 23KB)
• Presentation Slides (PDF - 1MB)
• FDA E2B(R3) Core Data Elements and Business Rules ver.2.00 - DRAFT (XLS) 
• FDA E2B(R3) Forward Compatible Rules - DRAFT (PDF)

July 17, 2019 meeting:

• Agenda (PDF - 23KB)
• Presentations Slides (PDF -3 MB)

March 25, 2019 meeting:

• Agenda (PDF - 26KB)
• Presentation Slides (PDF - 2.88MB)

Registration:

The public meeting series has now concluded.

Streaming Webcast and the Video of the Public Meeting:

Each public meeting will be webcast. A video recording of the public meetings will be available at the same website address for 1 year.

The webcast links from the February 19, 2020 meeting are available below:

• https://collaboration.fda.gov/pxss71e482yw/
• https://collaboration.fda.gov/p0u99p874fjw/
• https://collaboration.fda.gov/pzrz4cmjubgr/
• https://collaboration.fda.gov/pszyk7w2lh8f/

The webcast links from the July 17, 2019 meeting are available below:

• https://collaboration.fda.gov/ppkmmrbuk7x6/
• https://collaboration.fda.gov/pdlq0643grry/
• https://collaboration.fda.gov/pkrygx4qq3zk/
• https://collaboration.fda.gov/puej5e4vj9ev/

The webcast links from the March 25, 2019 meeting are available below:

Webinar:

Information on the webinar can be found here: https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/webinar-electronic-submission-adverse-event-reports-fda-adverse-event-reporting-system-faers-using . The purpose of this webinar is to provide information on the plans, progress, and technical specifications on enhancements to electronic submission of premarket and postmarket Individual Case Safety Reports (ICSRs) in FAERS using ICH E2B(R3) standards.

Comments on the Public Meeting:

Please refer to the Federal Register Notice on instructions for submitting either electronic or written comments on this public meeting. We request that comments are submitted before or within 30 days of each public meeting. 

The deadline for comments for the February 19, 2020 meeting is March 20, 2020.

Transcripts:

February 19, 2020 (PDF - 828KB)

Wednesday, July 17, 2019 (PDF -  829KB)

Monday, March 25, 2019 (PDF - 1MB)

The transcript will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff (see ADDRESSES in the Federal Register Notice). A link to the transcript is also available on the internet at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm115894.htm.

Contact Information:

Email: [email protected]

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