概览
The latest ICHE6 R2 guidance has driven even the nay-sayers to focus on developing RBM strategies. Without experience and expertise to support the same, one may actually end up adding risk to a study. The industry has an urgent need to understand the strategies involved in RBM, including the development of the IQRMP, the development of a risk scoring model, the identification of the KRIs, the SDV strategy, site-tiering strategy, the road-blocks and the pre-emptive measures, the identification of the proof points and the latest regulations and the tools and technologies involved. In addition, this conference will touch on the role of the risk based monitor and the criticality of a well outlined change management strategy.
项目委员会
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Nimita Limaye, PHD Research VP, Life Sciences R&D Strategy and Technology, at IDC
IDC, United States -
Abby Abraham, MPHARM Vice President, Data Analytics and Risk Based Monitoring
OmniComm Systems Inc, India -
Abhijit Arun Parab, MS Director - CDM and Programming
Allergan, United States -
Raghu Punnamaraju Senior Director, Software Engineering-R&D Engineering Management
PAREXEL International, India -
Sarvesh Singh, MBA, MSC Vice President Data Management
ICON, India
