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Clinical Aspects of Quality Risk Management and Quality by Design

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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.

Contact your regional office for future dates and locations.
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