Final Guidance to the ICH GCP E6 R2 – The changes and how to Implement


This training will look at the principles of risk management and how they apply in RBM. We will look at the changing regulatory environment with a focus on the changes outlined in ICH GCP E6 (R2) and how these changes may impact your clinical trials and processes.

During this training session, attendees will look at the principles of risk management and how they apply in adopting a RBM approach. We will look at the changing regulatory environment focusing on the revisions to ICH GCP E6 (R2) including challenges in implementing the changes. We will discuss cross industry initiatives and what your organization requires in order to meet regulatory expectations.

Areas Covered in the Session :

  • Review the principles of risk management and quality by design
  • How the principles apply in RBM
  • Discuss the changes in the regulatory environment
  • Discuss key changes to ICH GCP E6(R2)
  • Review the potential challenges and impact of the changes
  • Discuss the expectation of the regulatory bodies
  • Share best practice and discuss cross industry initiatives

Who Will Benefit:

  • Clinical Research Associates
  • Clinical Quality Auditors
  • Clinical Research Monitors
  • Data Management Teams
  • Project Management Statisticians
  • Drug Suppliers
  • Regulatory Affairs Teams
  • Compliance Teams
  • Clinical Study Teams
  • IRB/IECs
  • Site Personnel

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