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16th DIA Japan Annual Meeting 2019

Delivering Rational Medicine for All People in the Globe


[S13] Challenges on Implementation of Risk Based Approach and Its Foresight

Session Chair(s)

Shigeyoshi  Yokokawa, MSc

Shigeyoshi Yokokawa, MSc

  • Director, Regional Clinical Operations
  • Bristol-Myers Squibb K.K., Japan
Accompanied by implementation of ICH E6 R2, pharmaceutical companiesand CRO companies have taken the introduction of Risk Based Monitoring (RBM) into considerations, however, their stance is just like a “wait-and-see”. The primary objectives of RBM implementation are to ensure clinical trial data with high quality and to expect synergy brought by building processes at an investigational site and detecting issues promptly. On the other hand, it’s also true the discussion around its methodology is preceded. In this session, we would like to share the cases collaborated with an industry organization and investigational in accord with the results of survey. And we would also like to discuss our challenges on implementation of RBM which we have faced.

Speaker(s)

Yoko  Kurose, MPharm

Let’s Go Back Again to the Basics of RBM

Yoko Kurose, MPharm

  • Senior Manager, Monitoring Group
  • Pfizer R&D Japan, Japan
Toshiya  Hara

What is Required of CRAs in Relation to RBM? ~Problems Revealed from a Survey of Medical Institutions

Toshiya Hara

  • Executive Vice President
  • I'rom Co., Ltd., Japan
Minoru  Koizumi

Road to RBM Realization- Learning from Site Tour

Minoru Koizumi

  • Senior Associate, Clinical Development Consultant
  • Eli Lilly Japan K.K., Japan