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

Instructor

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.