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The Use of Mean Kinetic Temperature to Aid Evaluation of Temperature Excursions: Proper and Improper Application

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Contributors

  • Robert H. Seevers, Ph.D.

    Bob Seevers serves as a Senior Advisor for Pearl Pathways with over 40 years of experience in the pharmaceutical research and development. He has experience as an FDA reviewer/team leader, clinical investigator, and in industry. After 8 years with FDA, Bob spent 16 years with Eli Lilly and Company in Quality Assurance and Regulatory Affairs. He has led the regulatory CMC submission strategy for drugs in preclinical development through their NDA/MAA submission and the approval process for both small and large molecules.

    Bob’s expertise includes cold chain shipping, stability, determining regulatory starting materials, radiopharmaceuticals, setting global specifications, determining product critical quality attributes, quality by design (QbD), global regulatory submissions, and interactions with regulatory agencies. His knowledge spans the therapeutic areas of Central Nervous System, Endocrine, Metabolism, Autoimmune, Oncology, and more.
    As a Senior Advisor, Bob is responsible for the development of the regulatory strategy for early through late stage regulatory filings for both large and small molecules, interaction with global regulatory agencies, and leading cross-functional CMC development teams.
    Bob has spoken at numerous national and international conferences on regulatory issues, and has served as a WHO invited lecturer on drug registration. Bob holds a Bachelor’s Degree of Science in Chemistry from Lehigh University and a Ph.D. in Medicinal Chemistry from the University of Michigan.

July 9, 2020
Thu 12:30 PM EDT

Duration 1H 30M

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