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Effectively Managing Vendor Oversight

18 - 19 October 2017

Radisson Blu Edwardian Grafton, London

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 interactive two day course will provide a crucial overview of your responsibilities as a sponsor, giving you the knowledge you need to ensure quality oversight.

This course is also available for studying online, check website for dates>>

  • Get critical updates in regulatory expectations and requirements for vendor oversight
  • Determine critical success factors for selecting vendors and designing contracts
  • Discover key concepts for successful governance of oversight
  • Establish best practices for monitoring and implementing quality metrics
  • Implement time-saving project management strategies to ensure cost-effective vendor oversight
  • Learn from real life case studies: Discover when and why warning letters have been received in the past
  • Benefit from interactive practical exercises, designed specifically to enhance your oversight strategies

John Shillingford, PhD, is an independent consultant whose career in both the Pharmaceutical and CRO industries has stretched over 30 years.  His wide experience of drug development in Europe and the USA has been acquired during the management of both clinical and data operations for major global programs. A major focus has been to successfully commence and manage operations in the countries of Central and Eastern Europe and integrate these research units into global 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

The trainer has a wealth of knowledge and generously shared it with the participants. This training gave me a lot of ideas how to improve the vendor oversight in my company.


Senior Manager, Astellas

The practical insight on how CROs work in this course was excellent.

CSM, 

Santen

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• Risk Management for Outsourcing
• Risk Identification
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• 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.