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Archive: Quality Risk Management in Clinical Trials and Pharmacovigilance

Course #: BI12227
December 10, 2015

Course Description

The ICH Q9 Quality Risk Management (QRM) guideline has become an accepted standard, facilitating the development and implementation of a systematic risk-based approach to quality management of clinical trials and pharmacovigilance. Industry and regulatory bodies, including the EMA and FDA, have recognized the need and benefits of implementing a risk-based approach to quality management.

This web seminar is designed to provide a strong conceptual foundation of the principles of quality risk management with a clear focus on the application of these principles. We will address applying QRM to support decision-making throughout the clinical trial management and pharmacovigilance process, allocating limited resources effectively to areas of high risk, and preparing the participant to become an active contributor towards risk-based quality management at his/her organization.

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Learning Objectives

  • Define Quality Management System (QMS) levels for applicable areas in clinical trials and pharmacovigilance
  • Build quality at key points in the process
  • Apply QRM principles: Identification and quantification of key risk indicators
  • Implement a quality by design approach to overcome shortcomings in quality and compliance
  • Leverage existing information to support decision-making in resource allocation within clinical trials
  • Create a governance model to support mitigation strategies and the overall QMS infrastructure

Who Should Attend

  • Clinical Research, Operations, and Development Professionals
  • Medical Affairs Personnel
  • Safety and Risk Management/Operations Personnel
  • Compliance, Regulatory Affairs, and Clinical Quality Assurance Personnel


The course will be led by one of the following instructors:

Randy Ramin-Wright, M.Sc.

Click here for complete trainer biographies


Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.