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Session 05A: Continuous Manufacturing
Session Chair(s)
Moheb M. Nasr, PHD, MS
Principal, Nasr Pharma Regulatory Consulting, United States
Jean-Louis Robert, PHD
Former CHMP/CVMP QWP Chair, Luxembourg
Continuous manufacturing is gaining momentum in industry and is supported by major regulators. This session will assess industry implementation strategy, the current regulatory environment, and existing guidelines and their impact on manufacturing innovation. Presentations will outline key industry and regulatory concerns, gaps, challenges and propose a way forward to facilitate speedy implementation.
Industry and regulatory presentations will be followed by panel discussion.
Speaker(s)
Moheb M. Nasr, PHD, MS
Principal, Nasr Pharma Regulatory Consulting, United States
Regulatory and Quality Considerations for Continuous Manufacturing
Jean-Louis Robert, PHD
Former CHMP/CVMP QWP Chair, Luxembourg
Regulatory and Quality Considerations for Continuous Manufacturing
Moheb M. Nasr, PHD, MS
Principal, Nasr Pharma Regulatory Consulting, United States
Continuous Manufacturing – Implementation Strategy: Industry Perspective
Jean-Louis Robert, PHD
Former CHMP/CVMP QWP Chair, Luxembourg
Continuous Manufacturing – Regulatory Challenges and Opportunities