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18-Sep-2020 - 18-Sep-2020

J39 Vendor Oversight in Clinical Trials

  • Location:
    • Cedar Court
    • White Waltham
    • Maidenhead, Berkshire
    • SL6 3LW
    • England
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The Course

Vendor Oversight is currently a hot topic as sponsors and vendors aim to get to grips with what is really required.  You don’t want to outsource and then expend multiple resources to manage and oversee your trial.  As a vendor you want to get on with the outsourced clinical trial in the most effective way feasible without micromanagement from your sponsor company.   What is required to compliantly and efficiently implement vendor oversight? What are the risks and challenges of not getting this right from the beginning? This course will aim to work through some of these challenging topics with time given to work through specific scenarios from the attendees. 

Learning Objectives

• Understand  the regulatory expectations that impact Vendor management and Vendor Oversight including any up-coming revisions  • Understand different Outsourcing Models and what they mean when implementing effective Vendor management and Oversight. • Understand the requirements for selecting vendors to meet your outsourcing requirements • Understand expectations for Vendor Oversight and how to implement a practical vendor oversight plan. • Be aware of all of the components of vendor governances and understand what is right for your organization • Understand what makes excellent vendor management and oversight to support excellent delivery

Course Outline

• Meeting Regulatory Expectations: recent industry and regulatory items that impact Vendor Oversight to include proposed ICH E 6 revisions. • Understanding different outsourcing models: what could work best for your organization • Getting off on the right foot: Selecting the right providers for your outsourcing model • Vendor Oversight: what are the key components of Vendor oversight • Implementing an effective Governance Structure • Implementing Vendor Oversight to gain effective project delivery • Q&A on Vendor oversight and specific requirements