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[V1-S1] Update on ICH E18: Impact on Genomic Sampling and Management of Genomic Data in Clinical Trials
Session Chair(s)
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)
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
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
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
Astellas Pharma Inc., Japan
Manager, Clinical Pharmacology, Global Development
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