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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)
Moheb M. Nasr, PhD, MS
Principal, Nasr Pharma Regulatory Consulting, United States
Regulatory and Quality Considerations for Continuous Manufacturing – Key Findings from MIT 2016 Symposium
Yoshihiro Matsuda, DrMed
Principal Senior Scientist (for Quality), Pharmacist, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
PMDA Perspective on Continuous Manufacturing
Jean-Louis Robert, PhD
Former CHMP/CVMP QWP Chair, Luxembourg
EU Perspective on Continuous Manufacturing
Mahesh Ramanadham, PharmD, MBA
Deputy Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER , FDA, United States
FDA Perspectives on Continuous Manufacturing