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avatar for Ta-Jen Chen

Ta-Jen Chen

FDA, United States
Project Management Officer, OSP, CDER
Mr. Chen is a project management Officer at Office of Strategic Programs, CDER, US Food and Drug Administration, where he is responsible for the development and implementation of electronic data standards for CDER regulatory review. As an FDA delegate to ICH E2B Expert Working Group and ISO TC 215 WG 6, he has been actively participating in the development of E2B (R3) Implementation guide, ISO/HL7 ICSR message standard, and the ISO IDMP standards. TJ has more than 30 years of experience in program management and various data standards and message standards areas. He worked for a pharmaceutical company before join FDA in 2005.