10/10/2019

Topic: Contract Research Organization (CRO) Oversight after ICH E6(R2)

Date: October 22, 2019

Time: 1:00 p.m. – 2:00 p.m. EDT

Duration: 60 minutes

Sponsored by: Life Science Training Institute

Webinar: Live interactive session. Recording will be available for 30 days.

Sign up here.

Description:

Lack of Contract Research Organization (CRO) oversight is a common sponsor audit finding globally. In response, ICH E6(R2) Addendum strengthens the requirement for sponsors to “provide adequate oversight” of CROs when responsibilities are transferred. Risk-based and performance management strategies to CRO oversight are essential preventive actions.

Join Sandra “SAM” Sather for this interactive training session on the essentials of CRO Oversight post ICH E6(R2) addendum. Learn how the recent changes to GCP affect your risk analysis and action plans for CRO selection and oversight.

Key take away benefits:

Determine best practices for risk-based management of CROs.
Discover how quality risk management supports selection and oversight of CROs.
Learn how to use gap analysis for CRO selection and oversight.
Acquire preparation strategies for selecting CROs through scenarios.

- The Clinical Pathways Team

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