Risk-based Outsourcing

The regulatory background for the Pharmaceutical industry as a whole now requires a ‘risk based approach’ to all activities and that will of course include Outsourcing. Lack of Outsourcing Oversight is a very common finding during audits and regulatory inspections. One vital part of outsourcing is establishing adequate auditable documentation.

This course provides an understanding of risk management principles and makes the links necessary between them and the processes necessary for effective outsourcing.

Areas Covered in the Session :
Review the clinical outsourcing and the 5 steps of risk management
Outline why a ‘risk-based approach’ is necessary in vendor management
Review the process of vendor management and apply a risk based approach
Prioritise risks and plan mitigation actions during the vendor selection process
Examine the challenges with multiple contractors, 3rd party outsourcing and working with Academia

Who Will Benefit:
A must attend webinar for all:
Clinical Research Associates
Data Management Team
Project Management Statisticians
Clinical Research Outsourcing
Drug Suppliers
All clinical research professional embarking on a risk-based approach

Jane Tucker and Sue Fitzpatrick

Jane Tucker :
Over the past 28 years Jane has moved from routine data cleaning activities, via computer system validation onto training and data quality activities, eventually specializing in Quality Risk Management. Jane has worked for a variety of large pharmaceutical companies and CROs before retiring from GlaxoSmithKline. Jane now operates as a Risk Management Trainer and Consultant, specializing in Study Level Risk Management and Risk Based Monitoring as well as facilitation of risk assessment workshops.

Sue Fitzpatrick :
Sue Fitzpatrick joined the Pharmaceutical Industry in 1980. She has been responsible for the management and audit of CRAs and clinical trials in a wide range of therapeutic areas. As former Head of Education and Training at the Institute of Clinical Research she was responsible for the provision of training courses for the industry and postgraduate courses in collaboration with several UK Universities.

Sue continues her collaborations and is an accredited teacher with Cranfield University. Sue is currently a Director of Redtree people working on employability skills to help new entrants enter the sector. She has authored many articles and books on clinical research and career development topics. Sue is currently working on a book in Clinical and Healthcare Research for publication with the Oxford University Press.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance