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2nd ICH E6(R3) has ended
Thursday September 5, 2024 2:00pm - 2:45pm EDT
Discuss Oversight Measures that are Fit for Purpose and Related to Trial Risks, as Outlined in R3
  • Discuss the expansion of the sponsor’s responsibility for delegated activities
  • Recognize the expanded term of Service Provider and no longer CRO only
  • Evaluate new requirements for sponsors to qualify clinical service providers
  • Understand when documented agreements with service providers must be in place and updating requirements
  • Identify updates related to issue escalation
Speakers
avatar for Cheryl McCarthy, RQAP-GCP, CQA, CMDA.

Cheryl McCarthy, RQAP-GCP, CQA, CMDA.

Experienced GCP/Quality Professional
Thursday September 5, 2024 2:00pm - 2:45pm EDT

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