Back to Agenda
[V1-S1] Update on ICH E18: Impact on Genomic Sampling and Management of Genomic Data in Clinical Trials
Session Chair(s)
Akihiro Ishiguro, PHD
Head, PMDA Washington D.C. Office, 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
Deputy Director, Innovative Medicines, HQA/Licensing, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
E-18, Sample and Data Management-European Perspective
Christian Grimstein, PHD
Senior Director, Translational Regulatory Affairs, Oncology Reg Science, AstraZeneca, United States
ICH E18 Guideline: Genomic Sampling and Management of Genomic Data - Overview
Yu Sakamoto, RPH
Planning and Coordination Officer, Office of International Cooperation, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
PMDA Perspective on ICH E18 and Future Discussion for Implementation
Takao Yamazaki, PHD
Manager, Clinical Pharmacology, Global Development, Astellas Pharma Inc., Japan
Have an account?