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KFC Hall

Jan 29, 2015 9:30 AM - Jan 30, 2015 5:15 PM

1-6-1 Yokoami, Sumida-ku, Tokyo, 130-0015 Japan

18th Annual Workshop in Japan for Clinical Data Management

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Session 3 : Risk-based Monitoring

Session Chair(s)

Yumi Sugiura, MRCP

Yumi Sugiura, MRCP

Global Clinical Operations, Global Data Management and Centralized Monitoring

Bristol-Myers Squibb K.K., Japan

Mariko Mizumoto

Mariko Mizumoto

Associate Director, Electronic Data System Mgt Gr, Clinical Data & Biostats Dept

Daiichi Sankyo Co., Ltd., Japan

Case Study: Addressing Key Aspects of the EMA Refl ection Paper on Risk-based Quality Monitoring - Quality Tolerance Limits and Quality Report

Speaker(s)

Misato Kuwagaki, MS

Risk-based Monitoring - Lilly Experience

Misato Kuwagaki, MS

Eli Lilly Japan K.K., Japan

Associate Director, Data Sciences

Junichi Nikaido

Risk-based Monitoring – Novartis Experience

Junichi Nikaido

Novartis Pharma K.K., Japan

Field Operation 5, Japan International Clinical Research Operation Dept

William Andrew Lawton

Case Study: Addressing Key Aspects of the EMA Refl ection Paper on Risk-based Quality Monitoring - Quality Tolerance Limits and Quality Report

William Andrew Lawton

Risk Based Approach Ltd, United Kingdom

Director / Consultant

Kaori Watanabe, MPharm

Expectationsfor medical institutions ?the systemrequiredin medical institution?

Kaori Watanabe, MPharm

The University of Tokyo Hospital, Japan

CRC, Clinical Research Promotion Center

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