Designed to deliver a deep-dive into the topics that you value most.

Workshop A:  Critical to Quality Factors and Quality Tolerance Limits

October 24, 2022 | 9:00AM-12:00PM ET


Define and Implement Critical to Quality Factors, Quality Tolerance Limits, and Key Risk Indicators to Quickly Identify and Assess Risk

Workshop B: Challenges of Effective Vendor Oversight

October 24, 2022 | 9:00AM-12:00PM ET


Identify the Critical Components of an Effective Vendor Oversight Plan

Workshop C: End to End Protocol Risk Assessment

 October 24, 2022 | 1:00-4:00PM ET


A Learning and Practice Course on RQBM Requirement, Critical Risk Identification Skills, and Team Facilitation. Subjects will include:

  • Training on RBQM (QbD, QTLs, KRIs, Risk assessments, etc.)
  • Review a protocol in a team setting and:
    • Facilitate a study risk assessment with a RACT tool
    • Identify critical data and processes
    • Identify risks, evaluate and develop mitigation plans
    • Identify QTL parameters and KRIs
    • Draft a study monitoring approach

Workshop D: The Blind Spots Mirrors of Decentralized Clinical Trials

October 24, 2022 | 1:00-4:00PM ET


  • Should primary endpoints of current trials typically collected in the clinic need to be digitally redesigned for DCTs?
  • How can we use advanced analytics and AI to extract clinical insights otherwise invisible using traditional trial design?
  • Do we really have what we need to accurately interpret clinical data collected remotely when the context and circumstances of the patients are largely invisible?
  • Offering patients too much flexibility may compromise data integrity--where do we draw the line?