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Tokyo Big Sight

Nov 13, 2016 9:30 AM - Nov 15, 2016 5:30 PM

3-11-1 Ariake, Koto-ku, Tokyo, 135-0063 Japan

13th DIA Japan Annual Meeting 2016

[V2-S2] Continuous Manufacturing

Session Chair(s)

Yukio  Hiyama, PhD

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

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

Yoshihiro  Matsuda, PhD

PMDA Perspective on Continuous Manufacturing

Yoshihiro Matsuda, PhD

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Senior Scientist (for Quality), Pharmacist

Jean-Louis  Robert, PhD

EU Perspective on Continuous Manufacturing

Jean-Louis Robert, PhD

Luxembourg

Former CHMP/CVMP QWP Chair

Mahesh R. Ramanadham, PharmD, MBA

FDA Perspectives on Continuous Manufacturing

Mahesh R. Ramanadham, PharmD, MBA

FDA, United States

Deputy Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER

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