Summary
This two-day course gives you a theoretical and practical introduction to Risk-Based Quality Management (RBQM) and Quality by Design (QbD) in clinical trials, focusing on how to move from principles to effective implementation.
Through theory, practical examples, hands-on exercises and panel discussions, you learn how to identify what matters most for trial quality, including Critical-to-Quality (CtQ) factors, critical data and processes, and associated risks. You explore how to apply proportionate risk assessment, controls and monitoring strategies tailored to the specific study.
You also gain insight into ongoing risk oversight, including risk review, reassessment, communication and reporting, and explore practical approaches to overcoming common barriers to RBQM implementation.
You leave the course with a stronger understanding of how to embed quality into study design and apply RBQM throughout trial conduct in a practical, proportionate and effective way.
Key words
• Risk-Based Quality Management (RBQM)
• Quality by Design (QbD)
• Critical-to-Quality (CtQ)
• Risk Management
• Clinical Trials
• ICH E6 / GCP
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Course leader & lecturers
- Alicja Budek MarkCourse leaderDirector RBQM
Genmab A/S
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Is this course for you?
This course is for you if you are involved in planning, conducting or overseeing clinical trials. It is particularly relevant if you work as or within:
• Clinical Trial Manager/Lead
• Study/Project Manager
• Clinical Research Associate (CRA)/Monitor
• Clinical Operations
• Quality Assurance and Quality Management
• Medical and Clinical Development
• Data Management and Biostatistics
The course is also relevant if you work in another function involved in RBQM or clinical trial oversight.
What you will learn
- How the principles of RBQM and QbD relate to regulatory expectations
- How to identify CtQ factors and their associated critical data and processes, and how to describe and score the risks that affect them
- How to select proportionate controls and monitoring tactics based on the identified risks
- How to plan ongoing risk review, reassessment, communication and reporting Reflect on how different operating models can affect RBQM implementation, drawing on practical examples shared by peers.
- How different operating models affect RBQM implementation, illustrated by practical examples from peers
What your company will get
- An employee who has gained stronger capabilities to implement, enhance and oversee RBQM and Quality by Design in clinical trials.
- An employee who supports better risk-based decision-making, stronger quality oversight and more effective use of resources throughout the clinical trial lifecycle.
- An employee who can bring real-world RBQM challenges and implementation barriers to the course and explore practical solutions with peers and RBQM experts.
- An employee who is better equipped with practical knowledge, new perspectives and actionable approaches to strengthen and advance RBQM practices across the organisation.
Course calendar
Day 1
- From RBQM Principles to Critical Risks. RBQM evolution, regulatory expectations, and identifying risks to critical-to-quality factors and their associated data and processes.
- From design to delivery: monitor, learn and adapt. Setting up proportionate controls and monitoring tactics.
- From principles to practice: build your RBQM approach from Critical-to-Quality factors to proportionate monitoring.
- Closing the loop: review, reassess and communicate.
Day 2
- QbD in practice
- Risk management in practice
- Making RBQM work: from barriers to solutions. Panel discussion on overcoming the challenges.
Registration
Registration deadline10 Mar 2027
Lersø Parkallé 101
2100 København Ø
Course information
Literature
Prior to the course you get access to mandatory and/or optional readings via your personal Atrium log-in.
Prerequisites
Examination
There is no examination for this course.
Course leader
Genmab A/S
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Want to know more or need help?
Contact Client Manager Christina Spangsberg at +45 39 15 09 22
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