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DIA 2018 Global Annual Meeting

New Technologies in Pharmaceuticals and Biopharmaceuticals: Opportunities and Regulatory Challenges

    Session Chair(s)
      Representative Invited

      Representative Invited

      • European Medicines Agency (EMA), European Union, United Kingdom
    The session is intended to have a broad look at technology innovations and interactions with regulatory authorities in this area. The two key themes of continuous manufacturing and advanced therapy medicinal products are chosen to illustrate recent innovations. Topics included are: quality attributes, control strategy and advanced analytical methods, including PAT applications.The session will address both small and large molecules and give examples of complex biologicals, e.g. Gene and Cell therapy and CAR-T cells applications. Regulatory challenges for implementation of new technologies will be addressed, including possibilities for effective interaction with regulatory authorities.
    Learning Objective : Regulatory challenges and solution for new technology implementation
      Leslie  Weiss, MBA, RPh

      Global Approval and Acceptance of Continuous Manufacturing: Regulatory Opportunities

      Leslie Weiss, MBA, RPh

      • Director, CMC Regulatory Affairs
      • Janssen Research and Development LLC, United States
      Lucy  Chang, PhD

      Regulatory Challenges and Solutions for New Technology Development

      Lucy Chang, PhD

      • Director
      • Merck & Co., Inc., United States
      Representative Invited

      Gene and Cell Therapies: Innovations and New Technologies

      Representative Invited

      • European Medicines Agency (EMA), European Union, United Kingdom