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Identification of Medicinal Products: FDA's Perspective and Approach
Session Chair(s)
Ron Fitzmartin, PhD, MBA
Senior Informatics Advisor, Office of Regulatory Operations, CBER
FDA, United States
This forum will discuss FDA's perspective on the five ISO standards for Identification of Medicinal Products and its approach to conformance, as well as its collaboration with industry and other regulatory agencies.
Learning Objective : Identify the five ISO IDMP Standards; Describe FDA's approach to IDMP conformance; Explain the current scope of the FDA's IDMP approach.
Speaker(s)
FDA Update
Ta-Jen Chen, MS
FDA, United States
Project Management Officer, OSP, CDER
Defining Substances for the IDMP Using the GSRS
Lawrence Nicholas Callahan, PhD
FDA, United States
Chemist, OCS, OCPP, Office of the Commissioner
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