Cambridge Healthtech Institute’s 8th Annual

Risk-Based Quality Management

Clinical Trial Quality by Design and Throughout Execution

February 8-9, 2022


Advisory Board:
Laura Galuchie, Laura Galuchie, TransCelerate Program Lead, Oversight Committee, Merck
Andy Lawton, Director & Consultant, Risk Based Approach Ltd.
Michael Walega, Head, Centralized Monitoring, Bristol-Myers Squib


I am pleased to announce CHI’s 8th Annual Risk Based Quality Management being held February 8-9, 2022, at Rosen Shingle Creek in Orlando, FL. The gathering will be part of the 13th Annual Summit for Clinical Trials Operations Executives (SCOPE), a four-day cluster of events taking place February 7-10 that attracts more than 2,200 leaders in clinical innovation, operations and research. 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
  • Incorporating RBQM into decentralized trials
  • Regulations and guidelines which cover risk-based approaches to quality management
  • Operationalizing latest regulatory updates regarding risk management and clinical trial quality: ICH E6(R3), ICH E5 and E8
  • Metrics, QTL, KRI setup and monitoring
  • Protocol amendments and protocol deviations


*Also, please check out the Participant Engagement Award in honor of Gerald “Jerry” Matczak 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.


The deadline for priority consideration is July 23, 2021.


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’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.


For more details on the conference, please contact:

Bridget Kotelly 

Senior Conference Producer

Cambridge Healthtech Institute

Phone: (+1) 781-972-5404



For partnering and sponsorship information, please contact:

Companies A-K

Ilana Quigley

Sr. Manager, Business Development

Cambridge Healthtech Institute

Phone: (+1) 781-972-5457



Companies L-Z

Patty Rose

Sr. Business Development Manager

Cambridge Healthtech Institute

Phone: (+1) 781-972-1349


Submit a Speaker Proposal