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Effectively Managing Vendor Oversight - Online Academy

5 week online course beginning on Monday 5th February 2018

Online Academy

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.

This course is also available as a public training course - check the website for dates>>

• 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

Julianne Hull

With over 25 years’ experience in clinical development, 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). Julianne is now CEO of WenStar Enterprises, a company she formed to provide consultancy to the pharmaceutical industry in the areas of clinical outsourcing and operations.

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

Free webinars that may be interesting for you...

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FREE WEBINAR SERIES

Webinar 1: The effect of the contract on performance
Common sponsor concerns about partner performance, things that make people perform at their best, practical tips on getting it right

Webinar 2: A process for managing change
The 8 step approach to change, guides in managing change, example of process in action

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.