Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards - 07/17/2019 - 07/17/2019
- July 17, 2019
- July 17, 2019
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.
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
March 25, 2019 meeting:
To register for the second public meeting scheduled for July 17, 2019, please visit the following website: https://fdae2br3.eventbrite.com. The deadline for registration is June 14, 2019, 11:59 p.m. Eastern Time.
Please provide complete contact information for each attendee, including name, title, affiliation, address, email, telephone and method of attendance (in-person or web conference). Registration is free and based on space availability, with priority given to early registrants. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. If time and space permit, onsite registration on the day of the public meeting will be provided beginning at 8:00 a.m.
During online registration you may indicate if you wish to present during the public comment session. All requests to make oral presentations must be received by 11:59 p.m. Eastern Time on June 14, 2019, for the second meeting. Following the close of registration, we will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin and will select and notify participants by 11:59 p.m. Eastern Time on June 26, 2019. Further information will be made available on the Federal Register Notice.
Webcast Video of the Public Meeting:
Each public meeting will be webcast. The webcast URL for the July 17, 2019 meeting will be posted at least 1 day before the meeting. A video recording of the public meetings will be available at the same website address for 1 year.
The webcast links from the March 25, 2019 meeting are available below:
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 July 17, 2019 meeting is August 16, 2019.
The deadline for comments for the March 25, 2019 meeting was April 25, 2019. The comment period for that meeting is now closed.
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.