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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 CEO
    Nymro Clinical Consulting Services, India
  • Abby  Abraham, MPharm
    Abby Abraham, MPharm Co-founder & Vice President, Clinical Solutions
    Algorics, India
  • Abhijit  Parab, MS
    Abhijit Parab, MS Director - CDM and Programming
    Allergan, United States
  • Jeroze  Dalal
    Jeroze Dalal Global Trial Program Head
    Novartis HealthCare, India
  • 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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