Cambridge Healthtech Institute’s 3rd Annual

Implementing Risk-Based Monitoring – Part 1:  

Integrating Quality into Clinical Trials
January 24-25, 2017 | Hyatt Regency Miami | Miami, FL


Dear Colleague:

I am pleased to announce production of CHI’s 3rd Annual Implementing Risk-Based Monitoring – Part 1: Integrating Quality into Clinical Trials being held January 24-25, 2017 at the Hyatt Regency in Miami, FL.

The gathering will be part of the 8th Annual Summit for Clinical Trials Operations Executives (SCOPE), a three-day cluster of events that attracted 1,150 leaders in clinical operations and research in February 2016. Please see the overall program for 2017. Topics to be discussed at the Implementing Risk-Based Monitoring – Part 1: Integrating Quality into Clinical Trials 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
  • Effective QbD and risk assessment resources and tools for organizations of all sizes (small, mid-size and large pharma/biotech/CROs)
  • Methods to implement and modify TransCelerate’s Risk Assessment Categorization Tool (RACT) to fit small and mid-sized sponsor companies
  • Establishing an Integrated Quality Risk Management Plan (IQRMP)
  • Holistic approach to risk management - creating a clinical operations quality & risk framework and getting interdepartmental involvement (clinical ops, clinical supply, project management)
  • Change management/risk management adoption strategies and techniques
  • Implementing risk management program with limited resources and budget
  • Leveraging IT, tools and techniques for risk assessment in RBM
  • Latest regulatory updates regarding risk management: EMA guidelines, ICH E6
  • Establishing a framework for deploying RBM across the enterprise

If you are interested in presenting, please click here.

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 CHI 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.

Deadline for submission is June 15, 2016.

2017 SCOPE Conference at a Glance

SCOPE 2016 Wrap-Up

The 7th Annual SCOPE Summit, held February 23-25, 2016 in Miami, Florida, had record attendance with more than 1,150 industry leaders joining 3 days of in-depth discussions covering important issues in clinical trial planning and management. As SCOPE grew in attendance by 30% over last year, the 2016 program offered 12 distinct conference tracks, 2 symposia, 3 short courses, and 4 plenary keynote sessions, focused on advances and innovative solutions in all aspects of clinical trial management and operations, including Data Integration, Feasibility, Site Selection and Management, Patient Engagement, Recruitment and Retention, Mobile Tech, Project Management, Outsourcing, Forecasting, Budgeting and Contracting, Quality (QbD) in Trial Conduct, Risk-Based Monitoring, Post-Marketing Studies, Observational Research, Statistics and Biomarker-Driven Trials.

For Further Information

For questions or suggestions about the meeting, please contact:

Lee Yuan
Conference Director
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5404
E: lyuan@healthtech.com

For partnering and sponsorship information, please contact:

Ilana Quigley
Senior Manager, Business Development
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5457
E: iquigley@healthtech.com

For media and association partnerships, please contact:

Rich Handy
Senior Director, Marketing
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5456
E: rhandy@healthtech.com