Randolph Fillmore

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Florida Science Communications, Inc.
Director
Randolph Fillmore is the director of Florida Science Communications, Inc. He has a BS in Anthropology, an MA in Medical Anthropology, and an MA in Journalism. He has written on health care and health care policy, medical research, pharmaceutical and medical device regulation, public health, biology, chemistry, physics, pharmacy, and the social sciences. Formerly, he was employed as a science writer at the Johns Hopkins University School of Public Health and later at the University of Maryland Baltimore School of Pharmacy. He has been a member of the National Association of Science Writers since 1994.

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That question was at the heart of the of ISPE’s “Expert Xchange: Regulatory Summit on ICH Q9 Revision” held 9 June 2022. Seventy-one participants from 14 countries discussed ICH Q9(R1) and received valuable insight from several members of the Expert Working Group (EWG) assembled in 2020 to lead the ICH Q9 revision process. Discussion centered on the current state of application of quality risk...