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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)
Regulatory and Quality Considerations for Continuous Manufacturing
Moheb M. Nasr, PHD, MS
Nasr Pharma Regulatory Consulting, United States
Principal
Regulatory and Quality Considerations for Continuous Manufacturing
Jean-Louis Robert, PHD
Luxembourg
Former CHMP/CVMP QWP Chair
Continuous Manufacturing – Implementation Strategy: Industry Perspective
Moheb M. Nasr, PHD, MS
Nasr Pharma Regulatory Consulting, United States
Principal
Continuous Manufacturing – Regulatory Challenges and Opportunities
Jean-Louis Robert, PHD
Luxembourg
Former CHMP/CVMP QWP Chair