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          Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards - 04/04/2023News & Events for Human Drugs Public
    Event Title
              Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards


                  April 4, 2023 - November 7, 2023

  

    
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      Meeting Information
                Event MaterialsDate:
          
  


     
                                                       
       

April 4, 2023 - November 7, 2023   

 
 
        
                
                                      Day1: 
              Tue, Apr 4 9:00 AM
 - 3:00 PM
 ET
            
                      Day2: 
              Tue, Nov 7 9:00 AM
 - 12:00 PM
 ET
                
  Organized By: 
      Organizer
          CDER Offices and Divisions
          CBER Offices & Divisions

 

  The Food and Drug Administration (FDA) is announcing a series of two 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 updated 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:

**Past Meetings:**

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.
April 4, 2023, from 9:00 a.m. – 3:00 p.m.
November 7, 2023, from 9:00 a.m. – 12:00 p.m.

Registration:

Registration is closed.

Meeting Materials:

Federal Register Notice for April 4, 2023 and November 7, 2023 meetings.

Federal Register Notice**November 7, 2023 meeting:**

Agenda (PDF - 114KB)
	Presentation Slides (PDF - 1.49MB)**April 4, 2023 meeting:**

Agenda (PDF - 128KB)
	Presentation Slides (PDF - 2.8MB)Federal Register Notice for March 25, 2019, July 17, 2019, and February 19, 2020 meetings.

Federal Register NoticeFebruary 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)
	Presentation Slides (PDF -3 MB)March 25, 2019 meeting:

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

**Streaming Webcast of the November 7, 2023 Public Meeting**

Live Recording of the Meeting

**Streaming Webcast of the April 4, 2023 Public Meeting:**

Live Recording of the Meeting AM session

Live Recording of the Meeting PM session

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


Webinar:

Information on the webinar can be found here: Reporting Individual Case Study Reports (ICSRs) to FAERS Using ICH E2B R3 Standards. 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.

Transcripts:

February 19, 2020 (PDF - 828KB)

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

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

Tuesday, April 4, 2023 (PDF - 2.8 KB)

Tuesday, November 7, 2023 (PDF - 466 KB)

The transcript will be accessible at 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 FDA Adverse Event Reporting System (FAERS) Electronic Submissions.

Contact Information:

Email: eprompt@fda.hhs.gov





Event Materials

  Title
            File Type/SizeAgenda Adverse Events ICH E2B R3 Standards April 4 2023
              pdf               (128.34 KB)April 4, 2023 ePrompt Slides
              pdf               (3.19 MB)ICH E2B Standards meeting transcripts, Tuesday, April 4, 2023
              pdf               (2.78 MB)November 7, 2023 meeting Agenda
              pdf               (114.21 KB)November 7, 2023 ePrompt Slides
              pdf               (1.49 MB)ICH E2B Standards meeting transcripts, Tuesday, November 7, 2023
              pdf               (465.65 KB)

                                                                                  Content current as of:
      01/11/2024
         
                   
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