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

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... --------------------  FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.    Upcoming Training - https://www.fda.gov/cdersbia SBIA Listserv - https://public.govdelivery.com/accoun... SBIA 2021 Playlist -    • 2021 CDER Small Business and Industry Assi...   SBIA LinkedIn -   / cder-small-business-and-industry-assistance   SBIA Training Resources - https://www.fda.gov/cdersbialearn Twitter -   / fda_drug_info   Email - [email protected] Phone - (301) 796-6707 I (866) 405-5367