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