Toward Global Identification of Medicinal Products (IDMP) Implementation: A Focus on Biologics

Описание: 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: https://www.fda.gov/drugs/news-events...

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