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Hyatt Regency Bethesda

Apr 13, 2015 7:00 AM - Apr 15, 2015 12:00 PM

One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814-5326

CMC Workshop 2015

Session 05A: Continuous Manufacturing

Session Chair(s)

Moheb M. Nasr, PhD, MS

Moheb M. Nasr, PhD, MS

Principal

Nasr Pharma Regulatory Consulting, United States

Jean-Louis  Robert, PhD

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

Regulatory and Quality Considerations for Continuous Manufacturing

Moheb M. Nasr, PhD, MS

Nasr Pharma Regulatory Consulting, United States

Principal

Jean-Louis  Robert, PhD

Regulatory and Quality Considerations for Continuous Manufacturing

Jean-Louis Robert, PhD

Luxembourg

Former CHMP/CVMP QWP Chair

Moheb M. Nasr, PhD, MS

Continuous Manufacturing – Implementation Strategy: Industry Perspective

Moheb M. Nasr, PhD, MS

Nasr Pharma Regulatory Consulting, United States

Principal

Jean-Louis  Robert, PhD

Continuous Manufacturing – Regulatory Challenges and Opportunities

Jean-Louis Robert, PhD

Luxembourg

Former CHMP/CVMP QWP Chair

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