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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)
Ryosuke Sakai
Office of Non-clinical and Clinical Compliance, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Overview and status update of E6 GL(R2)
Makoto Hirose, MSC
Office Director, 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
Theresa Mullin, PHD
Associate Center Director - CDER, FDA, United States
FDA Perspective on Draft ICH E6(R2): Integrated Addendum to ICH E6(R1)-Guideline for Good Clinical Practice
Ann Meeker-O'Connell, MS
Executive Director, Monitoring Excellence Head, Novartis, United States
Expectations and Challenges for E6 GL from Industry and Academia Perspectives- From TransCelerate’s Perspectives
Satoshi Matsushita
Director, R&D QA Department, Janssen Pharmaceutical KK, Japan
Expectations and Challenges for E6 GLfrom Industry and Academia Perspectives- From JPMA’s Perspectives
Yasuhiro Fujiwara, MD, PHD
Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Expectations and Challenges for E6 GL from Industry and Academia Perspectives- From Clinical Site’s Perspectives
Tatsuya Murakami
Senior Director, Head of Clinical Operations, Pfizer R&D Japan G.K., Japan
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