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  5. Webinar: Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards - Oct. 11, 2019
  1. CDER Small Business & Industry Assistance (SBIA)

Webinar: Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards - Oct. 11, 2019

CDER Small Business and Industry Assistance Webinar Series

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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. This webinar will enhance the pharmaceutical industry’s knowledge of the processes needed to implement ICH E2B(R3) into their systems.

We encourage our participants to review the webcast videos, presentations, and transcripts from the March 25, 2019, and July 17, 2019, public meetings ahead of time.

TOPICS COVERED

  • FAERS II and E2B R3 Up Versioning Plans
    • Describe the objective, scope and timeline of E2B R3 regional implementation
  • E2B(R3) Regional Data Elements
    • Premarket safety reporting regional requirements
    • Postmarket safety reporting regional requirements
    • Postmarket combination product regional requirements
  • Updates on electronic submission routing mechanisms
    • Describe the different routing mechanisms to submit via ESG or Safety Reporting Portal
  • Testing ICH E2B (R3) Regional XML files
    • Describe the methods to test ICH E2B (R3) regional XMLs

INTENDED AUDIENCE

  • Pharmacovigilance experts focused on implementing safety databases and submitting safety reports to regulatory agencies
  • Regulatory affairs professionals who submit premarket safety reports
  • Consultants working to implement ICH E2B (R3) standards

FDA SPEAKER

Image of Suranjan De


Suranjan De, MS, MBA
Deputy Director
Regulatory Science Staff (RSS) | Office of Surveillance & Epidemiology | CDER | FDA


LEARNING OBJECTIVES

  • Understand FDA’s regional data elements for the implementation of ICH E2B(R3).
  • Enhance the pharmaceutical industry’s knowledge of the processes needed to implement ICH E2B(R3) and regional data elements into their systems.

CONTINUING EDUCATION

This course:

  • This course is eligible for 1 CE credit for physicians, nurses, pharmacists, or pharmacy technicians. Please refer to the course CE announcement for complete information.
  • Continuing education certificates are available only for those who attend in-person or via webcast in real-time. There is a two week deadline to obtain the certificate of attendance and complete the event survey.
  • has been pre-approved by RAPS as eligible for credits towards a participant’s RAC recertification upon full completion.
  • is eligible for SOCRA credit in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area. Candidate must provide documentation of participation.
  • has been pre-approved by SQA as eligible for 0.25 non-GCP or non-GLP units for every 1 hour of instructional time towards a participant’s RQAP re-registration.
  • ACRP provides research-specific continuing education for the completion of this activity. Contact hours are provided at 1 point/hour for at least 45-60 minutes of qualified material.

QUESTIONS

Please contact info@sbiaevents.com for all technical questions.

TECHNICAL INFORMATION

The audio for the event will be provided through your computer speakers via Adobe Connect (there will NOT be a teleconference number to dial into). We recommend that you test your PC or mobile device prior to the event and you join the event a few minutes early to address any issues.

To test your PC, please visit: Adobe Connect Diagnostic Test

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