Cambridge Healthtech Institute’s 8th Annual

Risk-Based Quality Management

Risk-Based Quality Management (RBQM) and Monitoring

14-15 October 2025

 

We are pleased to announce the production of Cambridge Healthtech Institute’s 8th Annual “Risk-Based Quality Management” being held 14-15 October 2025 at the InterContinental Barcelona-Fira Center in Barcelona, Spain.

 

As risk-based quality management (RBQM) has evolved over the past decade, sponsors and regulators are embracing risk-based approaches to monitoring clinical studies. However, the pathway for implementation and operationalisation can vary depending on company size, maturity, and culture of innovation. Leveraging centralized monitoring, advanced data management strategies, and new technologies can help stay ahead of the curve when study conditions change quickly. However, challenges still arise, such as quality oversight of data, data validity, organizational change management, and regulatory developments. This conference will look at how risk-based approaches are executed by industry leaders and innovators, how these approaches are received by regulators, and what insights can be gleaned through case studies and lessons learned. 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, six conference tracks 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 2025. Topics to be discussed at the “Risk-Based Quality Management” conference track include:

 

Coverage will include, but is not limited to:

 

  • 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

 

Do you have an idea for a Pre-Conference Workshop? 
If your company is interested in hosting a 1-hour workshop on Monday, 13 October, please submit your topic and faculty details via the podium presentation link below. Select the related track, complete the required sections of the form, and include “Pre-Con Workshop” in the Proposal Title.

 

The deadline for priority consideration is 3 March 2025.

 

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’s 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:

 


For more details on the conference, please contact:

Iris Goldman

Conference Producer

Cambridge Healthtech Institute

Email: igoldman@healthtech.com

 

For sponsorship information, please contact:

 

Companies A-F:

Ilana Quigley

Director, Sales

Cambridge Healthtech Institute

Phone: (+1) 781-972-5457

Email: iquigley@healthtech.com

 

Companies G-L:

Katelin Fitzgerald

Senior Manager, Business Development

Cambridge Healthtech Institute

Phone: (+1) 781-247-1824

Email: kfitzgerald@cambridgeinnovationinstitute.com

 

Companies M-V:

Jon Stroup

Lead Business Development Manager

Cambridge Healthtech Institute

Phone: (+1) 781-972-5483

Email: jons@healthtech.com

 

Companies W-Z:

Patty Rose

Vice President, Sales

Cambridge Healthtech Institute (CHI)

Phone: (+1) 781-972-1349

Email: prose@healthtech.com

 

For media and association partnerships, please contact:

Rich Handy

Associate Vice President, Marketing

Cambridge Healthtech Institute (CHI)

Phone: (+1) 781-972-5456

Email: rhandy@healthtech.com