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TransCelerate Event

Quality Risk Management Framework: Best Practices for Implementation of Risk Management in Clinical Development

This webinar took place on June 11, 2019. You can watch a recording of the webinar on our YouTube Channel and download a PDF of the presentation.

Effective quality risk management is fundamental to ensuring the protection of human subjects and reliability of clinical trial results during the conduct of clinical trials. Quality risk management supports effective delivery of clinical development programs and ultimately delivery of treatments to patients. Thus, risk management is a core element of an effective quality management system (QMS) as described in the TransCelerate Clinical Quality Management System (CQMS) conceptual framework. In addition, the landscape of quality risk management in clinical development evolves as regulatory authorities adopt elements of risk management to promote proactive quality management, for example ICH GCP E6 (R2) 5.0 Quality Management.

This webinar is designed for professionals from pharmaceutical, biotechnology and medical device companies; CROs; and other clinical trial service providers whose responsibilities involve the following:

  • Good Clinical Practice (GCP)
  • Clinical Quality Assurance (CQA)
  • Clinical Quality Control (CQC)
  • Clinical Trial Operations/Management
  • Clinical Research
  • Quality Management/Global Quality Management
  • Audits/Inspections
  • Compliance/Global Compliance
  • Data Management/Systems Operations
  • Clinical Monitoring