Cambridge Healthtech Institute’s 7th Annual

Risk-Based Quality Management

Integrating Quality into Clinical Trials to Ensure Effective Monitoring

March 2-3, 2021


I am pleased to announce CHI’s 7th Annual Risk-Based Quality Management being held March 2-3, 2021 at Rosen Shingle Creek in Orlando, FL. The gathering will be part of the 12th Annual Summit for Clinical Trials Operations Executives (SCOPE), a four-day cluster of events that attracted 2,200 leaders in clinical innovation, operations and research in 2020. Topics to be discussed at the Risk-Based Quality Management conference include:  


  • How to implement RBQM into clinical trials
  • Quality by Design and risk management in clinical trials
  • Regulations and guidelines which cover risk-based approaches to quality management
  • Operationalizing latest regulatory updates regarding risk management and clinical trial quality: EMA guidelines, ICH E6 R2, ICH E9
  • Case studies implementing RBQM from across academic research, government funded research, and small, mid-size and large pharma/biotech and medical device
  • Quality tolerance limits (QTLs) and key risk indicators (KRIs)
  • Protocol amendments and protocol deviations

Also, please check out the Participant Engagement Award in honor of Gerald “Jerry” Matczak, the SCOPE Scientific Symposium (SSS), and the Masters in Clinical Research Golf Tournament

If you would like to submit a proposal to give a presentation at this meeting, please click here.


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.


For more details on the conference, please contact:

Bridget Kotelly
Conference Producer

Cambridge Healthtech Institute (CHI)

Phone: (+1) 781. 972.5404 Email:


For partnering and sponsorship information, please contact:

Companies A-K

Ilana Quigley

Senior Manager, Business Development

Cambridge Healthtech Institute (CHI)

Phone: (+1) 781.972.5457



Companies L-Z

Patty Rose
Senior Manager, Business Development

Cambridge Healthtech Institute (CHI)

Phone: (+1) 781.972.1349