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Overview

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.

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Program Committee

  • Nimita  Limaye, PhD
    Nimita Limaye, PhD Practice Lead, Applied Technical Solutions; Chief Executive Officer
    Nymro Clinical Consultancy Services, India
  • Abby  Abraham, MPharm
    Abby Abraham, MPharm Vice President, Data Analytics and Risk Based Monitoring
    OmniComm Systems Inc, India
  • Abhijit Arun Parab, MS
    Abhijit Arun Parab, MS Director - CDM and Programming
    Allergan, United States
  • Raghu  Punnamaraju
    Raghu Punnamaraju Senior Director, Software Engineering-R&D Engineering Management
    PAREXEL International, India
  • Sarvesh   Singh
    Sarvesh Singh VP and Head APAC - DM
    ICON Clinical Research, India
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