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2020 ISPE Continuous Manufacturing Virtual Workshop


A New Decade for Continuous Manufacturing


Jun 24, 2020 12:00am ‐ Sep 11, 2020 6:08am

Description

A New Decade for Continuous Manufacturing

A New Decade for Continuous Manufacturing Continuous manufacturing for pharmaceutical and biopharmaceutical manufacturing is still in its infancy with only a limited number of products approved within the past 5 years. As we begin the third decade of the third millennium, we anticipate that bio/pharmaceutical manufacturing will continue to get smaller, faster, and smarter. In this opening conference session, a broad array of speakers from industry, academia, and regulatory agencies will provide their views on the state of continuous bio/pharmaceutical manufacturing today and predictions for its future.

  • Welcome and Opening Remarks
    Christine M. V. Moore, PhD, Conference Chair; Global Head and Executive Director, GRACS CMC Policy
    Merck  
  • Speaker Introductions
    Sharmista Chatterjee, PhD, Division Director
    OPMA, OPQ/CDER
  • ICH Q13 Guidance – Continuous Manufacturing of Drug Substance and Drug Product
    JRapti Madurawe, PhD, Division Director
    FDA/CDER/OPQ/OPPQ
  • End to End Collaboration to Transform Biopharmaceutical Development & Manufacturing
    John Erickson, PhD, Senior Fellow,
    National Institute for Innovation in Manufacturing Biopharmaceuticals NIIMBL
  • Perspectives on the Implementation of Continuous Manufacturing 
    Sarah O’Keefe, PhD, VP Small Molecule Design and Development
    Eli Lilly and Company

Moderator(s):

  • Christine Moore, PhD, Global Head and Executive Director, GRACS CMC Policy, Merck & Co., Inc.
  • Sharmista Chatterjee, PhD, Division Director, OPF, and Emerging Technology Team Member, CDER/FDA

Speaker(s):

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