Cambridge Healthtech Institute’s 7th Annual

Risk-Based Quality Management

Risk-Based Quality Management (RBQM) and Monitoring

29-30 October 2024

We are pleased to announce production of Cambridge Healthtech Institute’s Risk-Based Quality Management: Risk-Based Quality Management (RBQM) and Monitoring being held 29-30 October 2024 at the InterContinental Barcelona-Fira Center in Barcelona, Spain.

Clinical researchers and sponsors are embracing risk-based approaches to quality management and monitoring of clinical studies, but the pathway for implementation can vary depending upon company size, maturity, and culture of innovation. Companies utilising remote and centralized monitoring strategies are ahead of the curve when study conditions change quickly, particularly when quality is a foundational element throughout the study lifecycle. However, challenges can arise, such as quality oversight of data, data reliability and validation, organisational change management, and regulatory developments. The conference will look at how quality is baked into each element of clinical research, how risk-based approaches are executed by industry leaders and innovators, and how risk-based approaches are received by regulators. The gathering will be part of the Summit for Clinical Trials Operations Executives (SCOPE) Europe, a two-day event made up of shared plenary keynotes from biopharma thought leaders, four conferences focused on specific issues and functions within the clin ops, innovation and research enterprise, informal and interactive breakout discussion groups, and networking. Please see the overall program map below for 2024. Topics to be discussed at the Risk-Based Quality Management conference include:

Integration of RBQM and quality throughout clinical trial lifecycle
RBQM for decentralized and hybrid trials
Central monitoring, data integrity, and data validation
Risk-based data management
Regulatory outlook and quality factors in ICH E6 and E8
Quality oversight of real-world evidence (RWE) and ePROs
Change management and continuous improvement

The deadline for priority consideration is 2 April 2024.

All proposals are subject to review by session chairpersons and/or the Scientific Advisory Committee to ensure the overall quality of the conference program. Additionally, as per Cambridge Healthtech Institute policy, a select number of vendors and consultants who provide products and services will be offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships.

Opportunities for Participation: