Clinical Trial Innovation Summit  
Clinical Trial Oversight Summit

Cambridge Healthtech Institute’s Seventh Annual
Mastering Risk-Based Monitoring
Ensuring Quality and Effective Monitoring

May 9-10, 2016 | Westin Boston Waterfront | Boston, MA

Proactively building quality standards and risk management into the design and planning of clinical trials leads to higher quality clinical trials. Implementing quality standards early into the clinical trial lifecycle lays the foundation for successful risk-based monitoring (RBM). With wider industry adoption of RBM, Cambridge Healthtech Institute’s “Mastering Risk-Based Monitoring” conference offers case studies and practical solutions from across pharma and TransCelerate member organizations on effectively implementing quality risk management plans, assessing technology needs for RBM, and working with various stakeholders on effective roll out of RBM.

Laying the Groundwork for RBM with Quality Plans and Change Management

Co-Presentation: ICH E.6 Addendum & Change Management towards a Metrics Based Future

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

Jean Baumann, Change Management Specialist, JMB Consulting, LLC

Pfizer's GCP Quality Management System

Jonathan Rowe, Ph.D., MS, MA, Executive Director, Head of Quality Performance Management, Pfizer

Co-Presentation: A Practical Approach to Integrating Technology in the Design and Implementation of a Risk-Based Quality Management Program

Brian Nugent, Associate Director, PALM, Clinical Operations, Gilead Sciences

Angie Maurer, RN, BSN, MBA, Clinical Operations Consultant, PALM/Clinical Operations, Gilead Sciences

Case Studies and Lessons Learned on RBM

Lessons I Wish Someone Had Told Me: Risk-Based Monitoring Implementation Challenges

Sheryl Jacobs, Vice President, Global Study Operations, Amgen

A Practical Guide to Successful RBM Implementation

Stacy Foley, Project Director, Global Risk-Based Monitoring Implementation, Merck

Co-Presentation: Talk Title to be Announced

Kate Owen, Vice President, Clinical Trial Management, Novo Nordisk

Heather Achenbach, Senior Director, Clinical Trial Management, Novo Nordisk

New Tech, Tools and Techniques for RBM

Co-Presentation: A Case Study in Searching for a Technology Solution to Support Risk-Based Monitoring (RBM)

Mary Cusack, Associate Director, Bristol-Myers Squibb

Ed Kellar, ‎Director, Global Data Management Operational Support, Astellas


To submit a speaker proposal for Clinical Trial Innovation Summit 2016, please click here.

For questions or suggestions about the meeting, please contact:
Lee Yuan
Associate Conference Producer
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5404

For media and association partnerships, please contact:
Jaime Hodges
Marketing Manager
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5429

For partnering and sponsorship information, please contact:
Ilana Quigley
Sr Business Development Manager
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5457