Cambridge Healthtech Institute’s 5th Annual

Risk-Based Quality Management and Monitoring

Beyond COVID-19: Tools and Processes to Accelerate RBQM and Improve Monitoring

3-4 October 2022

We are pleased to announce production of Cambridge Healthtech Institute’s “Risk-Based Quality Management and Monitoring: Integrating Quality into Clinical Trials to Ensure Effective Monitoring” being held 3-4 October 2022 at the InterContinental Barcelona-Fira Center in Barcelona, Spain. SCOPE Europe will be a hybrid conference in 2022 serving both in-person and virtual attendees.

Where RBQM implementation had proceeded in a conservative, iterative manner pre-pandemic, the challenges presented during this unexpected crisis resulted in acceleration with respect to onsite and remote monitoring practices in clinical trials. With the backdrop of lessons from COVID-19, CHI’s 5th Annual Risk-Based Quality Management and Monitoring conference provides processes and tools for acceleration of RBQM implementation, regulatory requirements, QTL & KRI setup and monitoring, early risk and issue detection, and monitoring approaches. 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, 4 conference programs 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 2022. Topics to be discussed at the “Risk-Based Quality Management and Monitoring” conference program include:

Central and remote monitoring
Lessons learned from COVID-19
Metrics, QTL, KRI setup and monitoring
Data quality and analytics
Regulatory considerations, ICH E6 R2 and ICH E8 R1

If you are interested in presenting, please submit a speaking proposal for review.

We are looking for actual implementation stories and lessons learned, not theoretical talks. Co-presentations featuring speakers from different departments involved in the project are encouraged.

Please note that due to limited speaking slots, preference is given to pharmaceutical and biotech companies, regulators, and those from academic/hospital centers. Additionally, as per Cambridge Healthtech Institute’s policy, a select number of vendors/consultants who provide products and services to these biopharmaceutical companies are offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships.

For more details on the conference, please contact:

Bridget Kotelly

Conference Producer

Cambridge Healthtech Institute (CHI)

Phone: (+1) 781-972-5404

Email: bkotelly@cambridgeinnovationinstitute.com

For partnering and sponsorship information, please contact:

Companies A-K:

Ilana Quigley

Sr. Manager, Business Development

Cambridge Healthtech Institute (CHI)

Phone: (+1) 781-972-5457