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Sponsor and Regulator Challenges, Risks, and Mitigation Strategies for Ensuring Third-Party Oversight of Vendors: Is Your Study Data at Risk?
Session Chair(s)
Sherri Ann Hubby
Director, Clinical Quality Assurance
Vera Therapeutics, United States
As required by ICH E6(R2) and by regulators such as the FDA and MHRA, sponsors retain the ultimate responsibility for activities that are outsourced to vendors providing services critical to the successful outcome of a clinical study. Sponsors delegating study activities to a vendor or a vendor’s vendor should take measures to pre-identify risks and ensure the vendor and any subcontractors are consistently delivering products or services of acceptable quality. This and more will be presented in this session, including communication pathways between clinical teams and the quality teams, and types of plans for management of risks by clinical teams. Some of the challenges of managing CROs/other vendors will be discussed such as how vendors are evaluated – per study or across a program area and regional challenges. Who does the initial assessment of the vendor (the operational group or QA?). Risk-based approaches to vendor quality management will be presented that includes how the vendors can be risk assessed and audited, along with how the vendor risk assessment information flows to the assessor completing the tool. Lastly, examples of the type of documentation expected by the FDA and MHRA to demonstrate oversight of vendors will be presented.
Learning Objective : Explain how to perform a risk-based vendor assessment including how to pre-identify risks; Identify the different types of plans for managing risks to ensure that there is a communication pathway and recommendations to mitigate risks; Describe the documentation requirements by the FDA and MHRA to demonstrate oversight of vendors and any regional differences that may need to be considered; Discuss how to use the risk assessment data collection tools available to evaluate vendors.
Speaker(s)
Sponsor Challenges, Risks and Mitigation Strategies for in Assessing Vendors for Clinical Trials
Sherri Ann Hubby
Vera Therapeutics, United States
Director, Clinical Quality Assurance
Demonstrating Sponsor Oversight: Regulatory Perspectives
Gail Francis
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Expert Inspector, GCP
FDA Perspective
Cheryl Grandinetti, PharmD
FDA, United States
Associate Director for Clinical Policy, CDER/OC/OSI/DCCE
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