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[V2-S2] Continuous Manufacturing
Session Chair(s)
Yukio Hiyama, PhD
Visiting Researcher
National Institute of Health Sciences, Japan
Continuous manufacturing (CM) is one of future topics for ICH. Before the ICH activity starts, other activities such as the MIT Continuous Manufacturing Symposium, sales of manufacturing equipment for CM, and consultations between industries and regulatory agencies have taken place. This session will share regulatory perspectives on CM from the EU, FDA, and PMDA.
Speaker(s)
Regulatory and Quality Considerations for Continuous Manufacturing – Key Findings from MIT 2016 Symposium
Moheb M. Nasr, PhD, MS
Nasr Pharma Regulatory Consulting, United States
Principal
PMDA Perspective on Continuous Manufacturing
Yoshihiro Matsuda, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Senior Scientist (for Quality), Pharmacist
EU Perspective on Continuous Manufacturing
Jean-Louis Robert, PhD
Luxembourg
Former CHMP/CVMP QWP Chair
FDA Perspectives on Continuous Manufacturing
Mahesh R. Ramanadham, PharmD, MBA
FDA, United States
Deputy Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER