Cambridge Healthtech Institute’s Inaugural 

From QbD and Risk Assessment to
Risk-Based Monitoring

Laying the Foundation
February 24-25, 2015 | Hyatt Regency Orlando | Orlando, FL 

Building quality and risk management into the design and planning of clinical trials leads to earlier detection and resolution of issues and higher overall quality of clinical trials. Proactively applying Quality by Design (QbD) principles into clinical trials improves trial efficiency and ensures data quality. Cambridge Healthtech Institute’s Inaugural "From QbD and Risk Assessment to Risk-Based Monitoring” conference provides guidance on how to proactively build quality standards into clinical trial conduct with emphasis on identifying appropriate key risk indicators and critical-to-quality metrics, thereby laying the foundation for successful risk-based monitoring.


Case Studies on Proactive Quality Risk Management 

Quality by Design and Proactive Quality Risk Management: Planning for High Quality Clinical Trials 

David Nickerson, Senior Director, Clinical Quality Management, Pfizer 

Risk-Based Quality and Compliance Management in Clinical Trials with Combination Products 

Marina Malikova, Ph.D., Executive Director, Surgical Translational Research: Operations and Compliance, Surgery, Boston University Medical Center  

QbD and Risk Management: How One Company is Designing and Implementing a Solution 

Brian Nugent, Associate Director, Clinical Operations & Process, Gilead Sciences 


Quality & Risk Assessment for Risk-Based Monitoring 

Key Risk Indicators & Quality Metrics for RBM 

Speaker to be Announced 

FEATURED CO-PRESENTATION: Implementing RBM at Boehringer Ingelheim – The Quality by Design Aspects 

Andy Lawton, Global Head, Data Management, Biometrics & Data Management, Boehringer Ingelheim Ltd.  

Mary Mills, President, CRA Consultant, Mary Mills, LLC  



2015 Summit for Clinical Ops Executives (SCOPE) Conference at a Glance Large 

SCOPE 2014 Wrap-Up
Held February 4-6, 2014, in Miami, Florida, the 5th Annual SCOPE Summit gathered more than 700 industry leaders, an attendance increase of 18% from 2013, for three stimulating days of in-depth discussions covering important issues in clinical trial planning and management. With 11 different conference tracks, a Clinical Informatics News Best Practices Awards and two plenary keynote sessions, SCOPE offered advances and innovative solutions in all aspects of clinical trial management and operations, including Data Integration, Feasibility, Site Selection and Management, Recruitment and Retention, Social Media and Mobile Tech, Project Management, Forecasting, Aggregate Spend Compliance, Post-Marketing Studies, and Sample Logistics. The impressive executive audience at SCOPE came together for invaluable networking opportunities with more than 70% of the attendees titled as Executives from leading Pharma (16%), CRO (32%), and Biotech companies (26%). Industry leaders and key decision makers representing 16 different countries and more than 350 unique organizations shared case studies, collaborated on best practices and provided unique perspectives on poignant issues that the field currently faces.

For questions or suggestions about the meeting, please contact:
Lee Yuan
Associate Conference Producer
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5404
For partnering and sponsorship information, please contact:
Ilana Quigley
Manager, Business Development
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5457

For media and association partnerships, please contact:
Rich Handy
Senior Director, Marketing
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5456

About Cambridge Healthtech Institute (CHI)
Founded in 1992, Cambridge Healthtech Institute (CHI) ( is the preeminent life science network for leading researchers and business experts from top pharmaceutical, biotech and academic organizations. Delivering an assortment of resources such as events, reports, publications and eNewsletters, CHI's portfolio of products include Cambridge Healthtech Institute Events, Pharmaceutical Strategy Series, Barnett International, Insight Pharma Reports, Marketing Services, and Cambridge Healthtech Media Group.

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