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Online Course: Management Strategies for Vendor Oversight

5-week online course | 10 Modules | 2 hours per week
6 September – 8 October 2021

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It is essential for industry to employ efficient and accurate strategies for monitoring outsourced clinical trials to minimise the chances of receiving warning letters from competent authorities. Companies should have robust structures in place for successful vendor selection, contract design, quality monitoring and risk minimisation when outsourcing clinical trials to remain compliant.

Using a combination of theory and practical examples, this essential 10-module course will provide a crucial overview of your responsibilities as a sponsor, giving you the knowledge, you need to ensure quality oversight over 5 weeks.

Key Learning Objectives

  • Introduction to the complexities of vendor selection, management and oversight
  • Review of different outsourcing strategies and models
  • Different outsourcing models from strategy, through vendor selection and effective implementation
  • Comprehend your responsibilities as the sponsor both from GCP perspective and from vendor management perspective
  • Identify the right level of management and oversight
  • Understand the outsourcing strategies for selecting, monitoring and communicating with your service providers

Who Will Benefit

All professionals who are involved in vendor oversight will benefit from this course, including:

  • Clinical Outsourcing
  • Contracts and Outsourcing
  • Clinical Quality Assurance
  • Clinical Quality Control
  • Clinical Operations
  • Vendor Management
  • Global QA/Compliance
  • Regulatory Affairs


Julianne Hull

CEO, WenStar Enterprises


Free webinars that may be interesting for you…

Risk Management in Clinical Outsourcing

Managing risk is essential in good oversight of a clinical trial. In this webinar, the following points were discussed:

  • Risk Management for Outsourcing
  • Risk Identification
  • Risk Impact Mitigation through Risk Management
  • Risk Management Plan

This session was led by Julianne Hull. Julianne has successfully held global leadership roles in vendor management/outsourcing and clinical operations for several large and medium pharmaceutical companies (Pfizer, Wyeth, Marion Merrell Dow, Biogen Idec and Ipsen).


Management of your Vendors – Sponsor Responsibility

This webinar explores upcoming changes to Sponsor responsibility with the latest developments in ICH E6 Revision 2.

Over c.30 minutes, learn about the following:

  • Understand the ICH E6 Revision 2 changes
  • Explore how this will place a greater emphasis on Vendor oversight
  • Investigate ways to navigate these changes for Sponsors

Led by John Shillingford, trainer for PTI’s Effectively Managing Vendor Oversight training course.

Benefits of Learning Online

Informa Corporate Learning’s online courses are new digital, interactive and engaging educational experience designed to maximise learning for professionals with busy schedules and/or small training budgets.

Our online courses are perfect opportunity for busy professionals as they require just 2 hours per week of your time and include an interactive forum for you to ask direct questions about challenges you are facing to expert course leaders.

Modules are released on a weekly basis, so you can pace yourself alongside your peers and you will have access to a comprehensive set of assets to support your learning such as video content, quizzes and case studies.


Julianne provided bespoke training in Vendor Oversight for our department. The training was easy to follow, interactive and increased our understanding of the requirements and how to go about implementing.
Head of Clinical Development, Medium Biotech

Course Outline

Module 1: Introduction to outsourcing

  • The basics of outsourcing models and strategies
  • What to outsource: selection, goals and benchmarking
  • Vendor selection & management essentials to include timeframes
  • Regulatory Requirements and Quality expectations
  • Basics of vendor oversight and vendor management?
  • Metrics to drive transparent outsourcing
  • Vendor Governance


Module 2: Meeting regulatory expectations

  • Examining EU and US regulatory expectations and requirements
  • Exploring the evolution of vendor oversight: sponsors maintaining full accountability even with the complexity of outsourcing
  • Understanding transfer of obligations rather than transfer of responsibilities
  • Case studies: Examples of cases where the sponsor has failed to comply with regulation / received warning letters
  • How can sponsors ensure meeting regulatory expectations?


Module 3: Selection of the right outsourcing partners

  • Start with the end goal as a focus
  • Selecting a partner to fit your defined strategy
  • RFI, RFP
  • Bid Defence
  • Vendor capabilities assessment
  • Site inspections
  • Financial assessment and mock bids
  • Cost management versus getting it right first time
  • Core elements for contracts
  • Quality Agreements
  • Identifying, understanding and managing risk


Module 4: Vendor management: What are the key components of vendor management?

  • Vendor management: What are the key components of Vendor Management?
  • RACI
  • Ensuring and enabling operational deliverables
  • Monitoring and documentation of goals, deliverables and quality
  • What is the overarching concept for vendor management?
  • Operational Metrics
  • Achieving effective management across multiple service providers
  • Issue management and effective escalation processes


Module 5: Vendor oversight: What are the key components of vendor oversight?

  • What is difference between vendor management and vendor oversight?
  • What is defined as success for vendor oversight?
  • Define your oversight philosophy
  • Demonstrating control to inspectors
  • Effective shared risk approaches to vendor oversight: ‘Skin in the game’
  • Hands on/hands off – does it matter?
  • Auditing strategy: Reaffirmation of vendor capabilities and CAPA management


Module 6: What is governance? Implementing an effective governance structure

  • Ensuring organizational alignment to outsourcing strategy
  • What is required for effective governance of vendors
  • Designing a model to effectively manage and oversee multiple vendors
  • Roles and responsibilities in vendor management
  • Ensuring complementary relationships between QA and outsourcing
  • Business continuity


Module 7: Risk Management for Clinical Outsourcing

  • Risk Management for Outsourcing
  • Risk Identification
  • Risk Impact Mitigation through Risk Management
  • Risk Management Plan


Module 8: Maintaining healthy business relationships

  • Success strategies for effective communication
  • The right level of transparency
  • Overcoming challenges with change management
  • Case studies: Differing approaches taken by vendors


Module 9: Using metrics effectively when outsourcing

  • Metrics to measure your performance
  • Metrics to measure vendor’s performance
  • Metrics to drive transparency
  • Metrics to drive trust


Module 10: High level legal and financial considerations when outsourcing

  • Development of a contract
  • Key documents
  • Legal terms
  • Typical legal issues and how to overcome them
  • Financial Oversight

when & where

06 Sep - 08 Oct 2021

Online Course

On-site & in-house training

Deliver this course how you want, where you want, when you want – and save up to 40%! 8+ employees seeking training on the same topic?

Talk to us about an on-site/in-house & customised solution.


Still have a question?

Sushil Kunwar
Training Consultant
+61 (0)2 9080 4395

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