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Session 2: FDA Plenary - Global IDMP Implementation – Getting Closer to the Goal
Session Chair(s)
Ron Fitzmartin, PhD, MBA
Senior Advisor, Office of Regulatory Operations, CBER
FDA, United States
The Identification of Medicinal Products (IDMP) offers a global framework for unique identification and consistent documentation of medicinal products, facilitating information exchange among regulators, manufacturers, suppliers, and distributors.
This session will present an overview of the testing results for the Global Pharmaceutical Product Identification (PhPID) Service operating model, which generates global PhPIDs for marketed medicinal products. The model's readiness for deployment, including its software functionality, interoperability, processes, and business rules will be discussed.
Speaker(s)
Speaker
Ron Fitzmartin, PhD, MBA
FDA, United States
Senior Advisor, Office of Regulatory Operations, CBER
Speaker
Malin Fladvad, PhD, MSc
Uppsala Monitoring Centre, Sweden
Portfolio Officer
Speaker
Isabel Chicharo, MS
European Medicines Agency, Netherlands
Head of Regulatory Data Management
Speaker
Representative Invited
ANVISA, Brazil
Speaker
Philipp Weyermann, DrSc, MSc
Swissmedic, Switzerland
Head of Unit Regulatory Assessment 2
Speaker
Vada A. Perkins, DrSc, MSc
Boehringer Ingelheim, United States
Vice President, Global Head of Regulatory Intelligence & Policy
Speaker
Representative Invited
Health Canada, Canada