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Strategies for Effective Management and Oversight of Clinical Outsourcing to Ensure Regulatory Compliance

Overview

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.  

Areas Covered in the Session

  • Meeting Regulatory Expectations: recent industry and regulatory items that impact Vendor Oversight to include ICH E 6 R2
  • Outsourcing models: what could work best for your organization
  • Selecting the right providers for your outsourcing model
  • What are the key components of Vendor Oversight
  • Implementing an effective Governance Structure
  • Implementing effective Vendor Oversight and Management

Learning Objectives

  • Understand the regulatory requirements that impact Vendor management and Vendor Oversight including recent revisions
  • Explore different Outsourcing Models and what they mean when implementing effective Vendor management and Oversight
  • Explain the requirements for selecting vendors to meet your outsourcing requirements
  • Describe expectations for Vendor Oversight and how to implement a practical vendor oversight plan
  • Recognise the components of vendor governances and understand what is right for your organization
  • Evaluate what makes excellent vendor management and oversight to support clinical trial delivery


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