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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

[V1-S1] Update on ICH E18: Impact on Genomic Sampling and Management of Genomic Data in Clinical Trials

Session Chair(s)

Akihiro  Ishiguro, PhD

Akihiro Ishiguro, PhD

Deputy Review Director, Office of New Drug III

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

The E18 expert working group (EWG) will work toward finalizing the E18 guideline by 2017, focused on technical aspects of genomic sampling and highlighting the value and importance of defining an appropriate methodology for genomic sample collection and data generation. This session will not only provide an update on the outcome of the E18 EWG from the ICH Osaka meeting held just before this meeting, but also follow-up discussions including remaining challenges for proper implementation of E18 guideline with key E18 members from the EU, Japan, and the US.

Speaker(s)

Krishna  Prasad, DrMed, MD, MRCP, FRCP

E-18, Sample and Data Management-European Perspective

Krishna Prasad, DrMed, MD, MRCP, FRCP

Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Deputy Director, Innovative Medicines, HQA/Licensing

Christian  Grimstein, PhD

ICH E18 Guideline: Genomic Sampling and Management of Genomic Data - Overview

Christian Grimstein, PhD

AstraZeneca, United States

Senior Director, Translational Regulatory Affairs, Oncology Reg Science

Yu  Sakamoto, RPh

PMDA Perspective on ICH E18 and Future Discussion for Implementation

Yu Sakamoto, RPh

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Planning and Coordination Officer, Office of International Cooperation

Takao  Yamazaki, PhD

Takao Yamazaki, PhD

Astellas Pharma Inc., Japan

Manager, Clinical Pharmacology, Global Development

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