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  4. Toward Global Identification of Medicinal Products (IDMP) Implementation: A Focus on Biologics - 01/27/2022
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Webcast | Virtual

Event Title
Toward Global Identification of Medicinal Products (IDMP) Implementation: A Focus on Biologics
January 27, 2022

Date:
January 27, 2022
Time:
9:00 a.m. - 10:30 a.m. ET

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ABOUT THIS WEBINAR

In this webinar FDA subject matter experts and guest speaker will:

  • Provide an overview of FDA’s regulatory approach to Identification of Medicinal Products (IDMP)
  • Address the status of the planned ISO updates to several IDMP standards
  • Discuss FDA’s international collaboration with WHO and other regulators focused on global implementation
  • Present examples of use cases for IDMP for both drugs and biologics

TOPICS COVERED

  • IDMP Overview
  • Current challenges with the IDMP standards and mitigation solutions using pilot projects
  • IDMP use cases for drugs and biologics
  • Path to Global Implementation

INTENDED AUDIENCE

  • Regulatory affairs professionals working on data standards, pharmacovigilance, product labelling, and electronic regulatory submissions
  • IT professionals focused on the electronic exchange of medicinal product information
  • Healthcare professionals preparing and submitting Individual Case Safety Reports (ICSRs)
  • International regulators and consultants focused on data standards, pharmacovigilance, product labelling, and electronic regulatory submissions

FDA SPEAKERS

Ron Fitzmartin, PhD, MBA
Sr. Informatics Advisor
Office of the Director
Center for Biologics Evaluation and Research (CBER) | FDA

Ta-Jen Chen
Sr. Project Management Officer
Office of Strategic Programs (OSP)
Center for Drug Evaluation and Research (CDER) | FDA

Vada A. Perkins, MSc, MS
Executive Director, Regulatory Policy & Innovation
Bayer Pharmaceuticals

  • European Federation Pharmaceutical Industries & Associations (EFPIA) European Regulatory Affairs and Operations (ERAO) Working Group
  • Pharmaceutical Research and Manufacturing Association (PhRMA) IT Working Group
  • ISO TC 215 WG 6 IDMP Co-chair
  • ICH M2 EFPIA Topic Lead

FDA RESOURCES

Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.

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