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Wednesday, June 26 • 2:00pm - 3:15pm
#360: Identification of Medicinal Products: FDA's Perspective and Approach

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-684-L04-P; CME 1.25; IACET 1.25; RN 1.25

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 Objectives

Identify the five ISO IDMP Standards; Describe FDA's approach to IDMP conformance; Explain the current scope of the FDA's IDMP approach.

Chair

Ron D. Fitzmartin, PhD, MBA

Speaker

FDA Update
Ta-Jen Chen, MS

Defining Substances for the IDMP Using the GSRS
Lawrence Nicholas Callahan, III, PhD



Speakers
TC

Ta-Jen Chen

Project Management Officer, OSP, CDER, FDA
TJ is a project management Officer at Office of Strategic Programs, CDER, FDA, where he is responsible for the development, testing, and implementation of electronic data standards for CDER regulatory review. As a FDA delegate to ICH E2B Expert Working Group and ISO TC 215 WG 6, he... Read More →
avatar for Ron Fitzmartin

Ron Fitzmartin

Sr. Informatics Advisor, FDA
Ron Fitzmartin is Senior Project Manager, Office of the Director, Center for Biologics Evaluation and Research, Food and Drug Administration. In this role Ron provides policy and strategy consultation and support on a wide range of topics focused on electronic regulatory submissions... Read More →
LC

Lawrence Callahan

Chemist, OCS, OCPP, Office of the Commissioner, FDA
Larry Callahan obtained his Ph.D. in Chemistry from the University of Chicago. He was previously employed at FDA, NIH and the United States Pharmacopiea (USP). He has been involved in Nucleic Acid, HIV, tuberculosis research and the development of analytical methods for biotechnology-derived... Read More →


Wednesday June 26, 2019 2:00pm - 3:15pm
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA