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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

[V3-S1] Expectations for ICH Q12

Session Chair(s)

Haruhiro  Okuda, PhD

Haruhiro Okuda, PhD

Deputy Director General

National Institute of Health Sciences, Japan

ICH Q12 is a guideline on technical and regulatory considerations for pharmaceutical product life cycle management. This guideline will focus on activities after approval, especially on how to proceed change control processes effectively. For global companies, the difference of the change control processes among countries prevents continuous improvements and innovations. While ICH Q12 is still under development, we would like to take this opportunity to share expectations on this new guideline from EU, FDA, and PMDA.

Speaker(s)

Moheb M. Nasr, PhD, MS

ICH Q12 – Progress Update

Moheb M. Nasr, PhD, MS

Nasr Pharma Regulatory Consulting, United States

Principal

Yasuhiro  Kishioka, PhD

ICH Q12 (Pharmaceutical Product Life Cycle Management): PMDA Perspective

Yasuhiro Kishioka, PhD

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Reviewer Director, Office of Cellular and Tissue-based Products

Jean-Louis  Robert, PhD

EU Perspective on ICH Q12

Jean-Louis Robert, PhD

Luxembourg

Former CHMP/CVMP QWP Chair

Mahesh R. Ramanadham, PharmD, MBA

FDA Perspectives on ICH Q12

Mahesh R. Ramanadham, PharmD, MBA

FDA, United States

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

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