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

Quality Risk Management Framework: Best Practices for Implementation of Risk Management in Clinical Development;  11June2019 10am-11:30am EDT

Quality Risk Management Webinar Recording

 
 
 

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.

Two free webinar sessions will be held (identical content will be covered at each session):

Learning Objectives:

  • Understand the implications of ICH E6 R2 and the impact to your clinical risk management practices must evolve to be compliant
  • Apply the conceptual framework for quality risk management as part of a CQMS
  • Learn to use the quality risk management components, including foundational elements, methods, and tools-Understand the implications of ICH E6 R2 and the impact to your clinical risk management practices must evolve to be compliant

Target Audience:

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

 

TransCelerate Clinical QMS Webinar Series -- this webinar topic is one of two that will educate and inform interested audience members about the TransCelerate Clinical Quality Management System (CQMS) conceptual framework, as well as the Risk Management and the Processes Frameworks published by TransCelerate. 

Visit our web page and publications to learn more:

June 11th 2019 from 10:00 AM to 11:30 AM GMT -5



Speakers