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SESSION 2:UPDATE ON ICH GUIDELINES Track 2 E6 – Impact on Clinical Operations
Session Chair(s)
Satoshi Saeki, MSc
Head of Japan Operational Excellence, Medical Affairs, Japan, Astellas Pharma Inc., Japan
Speaker(s)
Overview and status update of E6 GL(R2)
Ryosuke Sakai
Office of Non-clinical and Clinical Compliance, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Regulator’s Expectations and Future Impacts on E6 GL- From PMDA’s Perspectives
Makoto Hirose, MSc
Office Director, Office of Non-clinical and Clinical Compliance, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
FDA Perspective on Draft ICH E6(R2): Integrated Addendum to ICH E6(R1)-Guideline for Good Clinical Practice
Theresa Mullin, PhD
Associate Center Director - CDER, FDA, United States
Expectations and Challenges for E6 GL from Industry and Academia Perspectives- From TransCelerate’s Perspectives
Ann Meeker-O'Connell, MS
Executive Director, Monitoring Excellence Head, Novartis, United States
Expectations and Challenges for E6 GLfrom Industry and Academia Perspectives- From JPMA’s Perspectives
Satoshi Matsushita
Director, R&D QA Department, Janssen Pharmaceutical KK, Japan
Expectations and Challenges for E6 GL from Industry and Academia Perspectives- From Clinical Site’s Perspectives
Yasuhiro Fujiwara, MD, PhD
Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Tatsuya Murakami
Senior Director, Head of Clinical Operations, Pfizer R&D Japan G.K., Japan
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