Cambridge Healthtech Institute’s 6th Annual

Implementing Risk-Based Monitoring – Part 1

Integrating Quality into Clinical Trials

February 19-20, 2020


I am pleased to announce CHI’s  Annual “Implementing Risk-Based Monitoring – Part 1” being held February 19-20, 2020 at the Hyatt Regency Orlando in Orlando, FL. The gathering will be part of the 11th Annual Summit for Clinical Trials Operations Executives (SCOPE), a four-day cluster of events that attracted 2,000 leaders in clinical innovation, operations and research in 2019. Topics to be discussed at the “Implementing Risk-Based Monitoring – Part 1” conference include:  

  • Identification, prevention, mitigation and management of risk in clinical trial studies
  • Building QbD and risk management into clinical conduct starting with protocol development and study set-up
  • Addressing protocol amendments and protocol deviations
  • Operationalizing latest regulatory updates regarding risk management and clinical trial quality: EMA guidelines, ICH E6 R2, ICH E9
  • Clinical quality in action – creating a quality culture in organization
  • CRO/ vendor oversight, quality, and ICH E6
  • Quality tolerance limits (QTLs) and key risk indicators (KRIs)
  • Effective QbD and risk assessment resources and tools for organizations of all sizes (small, mid-size and large pharma/biotech/CROs)
  • Establishing Clinical Quality Management Systems
  • Holistic approach to risk management & implementing risk management enterprise wide - creating a clinical operations quality & risk framework and getting interdepartmental involvement (clinical ops, clinical supply, project management) 
  • Implementing risk management program with limited resources and budget
  • Regulatory inspection trends & audit findings: lessons learned from inspections of RBM trials
  • How to address audit findings & site audit process
  • Intersection of quality & RBM

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

The deadline for priority consideration is May 30, 2019.

All proposals are subject to review by session chairmen 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:

Marina Fishtinsky, MD

Executive Director, Conferences

Cambridge Healthtech Institute

Phone: (+1) 781.972.5496


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