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Tuesday, June 16 • 11:30am - 12:30pm
#224 SL: Sponsor and Regulator Challenges, Risks, and Mitigation Strategies for Ensuring Third-Party Oversight of Vendors: Is Your Study Data at Risk?

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-644-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.

Chair

Sherri Ann Hubby

Speaker

Sponsor Challenges, Risks and Mitigation Strategies for in Assessing Vendors for Clinical Trials
Sherri Ann Hubby

Demonstrating Sponsor Oversight: Regulatory Perspectives
Gail Francis

FDA Perspective
Cheryl Grandinetti, PharmD



Speakers
avatar for Gail Francis

Gail Francis

Expert Inspector, GCP, Medicines and Healthcare products Regulatory Agency (MHRA)
Gail Francis joined the MHRA in November 2003 as a GCP Inspector. Prior to joining the MHRA, Gail spent approximately 10 years in the Pharmaceutical industry. Her first role in the Pharmaceutical Industry was in Pharmacovigilance, before moving into Clinical Research and has held... Read More →
avatar for Sherri Hubby

Sherri Hubby

Director, Vendor Compliance, Gilead Sciences
Sherri A. Hubby has over 20 years of Global Quality Assurance management, auditing and training experience with emphasis in the GCP and GMP area for vendors, and sites including inspection hosting experience for the (CRO)/Pharmaceutical/Biotech/Medical Device and IRB industry. In... Read More →
avatar for Cheryl Grandinetti

Cheryl Grandinetti

Clinical Pharmacologist, OSI, OC, CDER, FDA
Dr. Grandinetti is a reviewer in the Good Clinical Practice Assessment Branch of the Division of Clinical Compliance Evaluation /Office of Scientific Investigations in CDER/FDA. She provides regulatory and scientific oversight for CDER-assigned bioresearch monitoring activities and... Read More →


Tuesday June 16, 2020 11:30am - 12:30pm
TBD Virtual Event Horsham, PA 19044