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New Technologies in Pharmaceuticals and Biopharmaceuticals: Opportunities and Regulatory Challenges
Session Chair(s)
Peter Richardson, PhD
Head of Quality, Specialised Scientific Disciplines Department
European Medicines Agency, Netherlands
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 : Identify recent technological developments and regulatory challenges in their implementation; Describe continuous manufacturing and how complex biological products are characterized and control strategies are developed; Discuss possibilities for interaction with regulatory authorities on development of innovative products
Speaker(s)
Global Approval and Acceptance of Continuous Manufacturing: Regulatory Opportunities
Leslie Weiss, MBA, RPh
Janssen Research and Development LLC, United States
Director, CMC Regulatory Affairs
Regulatory Challenges and Solutions for New Technology Development
Lucy Chang, PhD
Merck & Co., Inc., United States
Executive Director
Innovative Manufacturing for Cell and Gene Therapies
Michael Havert, PhD
StrideBio, United States
Vice President, Regulatory Affairs
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