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Clinical Aspects of Quality Risk Management and Quality by Design


This course will deliver an in-depth overview of risk-based quality management, including how to assess risk and improve quality within an organisation. As an introduction, general risk management concepts and methodologies will be presented as the basis for Quality Risk Management (QRM) in clinical development and pharmacovigilance. This will be followed by a review of applicable and meaningful metrics for clinical development and pharmacovigilance processes, how these can be best applied, and what change management challenges need to be considered. This is a beginner/intermediate-level course.

What you will learn

  • General risk management
  • The latest update on QRM regulations
  • QRM methodologies such as Failure Mode and Effects Analysis (FMEA)
  • Key Risk Indicators (KRI) and other tools
  • Implementation of QRM and change management aspects
  • Proactive Quality by Design (QbD) aspects

Who should attend?

  • Clinical study managers
  • Clinical study monitors
  • Country study managers
  • Clinical quality assessment professionals
  • Compliance and regulatory affairs professionals
  • Project managers
  • Risk management officers

Learning objectives

Participants who complete this course should be able to:

  • Define risk management and how it applies to clinical development
  • Describe how risk management has been successfully applied in other industries
  • Demonstrate the basic concepts and requirements for developing and implementing a QRM system
  • Identify key tools and standards to use in risk management
  • Evaluate how methodologies such as FMEA can be leveraged when introducing quality risk management in clinical development and pharmacovigilance

Contact us

DIA Europe
Kuechengasse 16, Postfach
4002 Basel, Switzerland
Phone: +41-61-225-51-51
Fax: +41-61-225-51-52
Email: mailto: