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avatar for Norman Schmuff

Norman Schmuff

FDA, United States
Associate Director for Science, OPMA, OPQ
Norman R. Schmuff joined the FDA in 1990. For more than 20 years, he has participated in ICH as a member of several Expert Working Groups. He was the Rapporteur for the M4 CTD (eCTD) – Quality Implementation Working Group. He is involved in many FDA electronic submission initiatives, including the Pharmaceutical Quality/Chemistry, Manufacturing, and Controls structured data project. He is also serves as a delegate to the International Organization for Standardization's (ISO) Technical Committee (TC 215) on health informatics which deals with the IDMP standards. Currently he is Associate Director in FDA’s Office of Process and Facilities in CDER. He has never served time in prison.

My Speakers Sessions

Tuesday, June 18
 

8:00am PDT

#205: Data Standards SOS: Reducing Burnout and Navigating Through Fatigue - Part 1 Room 2

10:00am PDT

#224: Data Standards SOS: Reducing Burnout and Navigating through Fatigue - Part 2 Room 2
 
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