FDA subject matter experts and guest speaker 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, and discuss FDA’s international collaboration with WHO and other regulators focused on global implementation.
Presenters:
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
For slides and additional information: [ Ссылка ]
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