Implementing Risk-Based Monitoring – Part 1

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. Cambridge Healthtech Institute’s "Implementing Risk-Based Monitoring – Part 1: Integrating Quality into Clinical Trials” conference provides guidance on how to proactively build quality standards into clinical trials with emphasis on the latest quality standards established by TransCelerate and CTTI, thereby laying the foundation for successful risk-based monitoring.

Stay on and attend Implementing RBM - Part 2: Effective and Efficient Monitoring
Keynotes | Monday Short Courses | Speaker Biographies

Monday, February 22

Recommended Pre-Conference Short Course
2:00 pm - 5:30 pm

SC3: Views and Conversations on Risk-Based Monitoring* - Detailed Agenda

*Separate registration required

Welcome and Networking Happy Hour on the Patio hosted by CHI, DrugDev and Praxis
7:00 pm - 9:00 pm

Tuesday, February 23 – Wednesday, February 24


Exploring the Need to Improve Clinical Trial Awareness

Kelly McKee, Recruitment, Retention and Innovation Team Lead, Global Trial Optimization, Merck & Co., Inc.

ROI Expectations and Objectives for Optimized Patient Awareness and Engagement

Kenneth Getz, MBA, Director, Sponsored Research Programs, Tufts CSDD; Chairman, CISCRP

AN INTERACTIVE MULTI-STAKEHOLDER ADVISORY PANEL: Increasing Clinical Trial Awareness: Who, What, Where, HOW?


Kelly McKee, Associate Director, Global Trial Optimization, Clinical Development Execution Organization, Merck & Co., Inc.

Kenneth Getz, MBA, Director, Sponsored Research Programs, Tufts CSDD; Chairman, CISCRP


Joe Kim, Senior Advisor, Clinical Development Innovation, Eli Lilly and Company

Mark Sloan, M.D., Hematology & Medical Oncology, Boston Medical Center

Carley Medosch, MBA, Chronic Illness Advocate

Andrew Lee, M.D., Senior Vice President & Head, Global Clinical Operations, Merck & Co., Inc.

For more details on the Tuesday Opening Plenary Keynote and Wednesday Afternoon Plenary Keynote click here.

Grand Opening Coffee Break in the Exhibit Hall


Integrating Quality to Expedite Innovation

Ann Meeker-O’Connell, MS, Head, Risk Management and External Engagement, Bioresearch Quality & Compliance, Janssen Pharmaceuticals, Inc.

Update on ICH E6

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

Talk Title to be Announced

Susan Callery-D’Amico, Vice President, R&D Quality Assurance, AbbVie


Quality by Design Case Study: Can You Really Create a Bullet Proof Quality Protocol?

Sheri Kuss, Quality and Compliance Manager, Clinical Quality Control & Compliance, Clinical Operations, CSL Behring

Bio Clinica LogoQuality by Design: An Intelligent Approach to Clinical Trial Monitoring

Courtney McBean, Vice President, Clinical Innovation


How to Implement a Risk-Based Quality Management Program (RBQM): From Development to Implementation and Everything in Between

Brian Nugent, Associate Director, PALM, Clinical Operations, Gilead Sciences
Angie Maurer, RN, BSN, MBA, Clinical Operations Consultant, PALM/Clinical Operations, Gilead Sciences

Interactive Breakout Discussion Groups

Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the more poignant questions facing the industry. Delegates will join a table of interest to them and become an active part of the discussion at hand. It is an informal, yet informative, format that allows attendees to learn from each other and make some new contacts. To get the most out of this interactive format please come prepared to: share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing.

View Detailed Interactive Breakout Discussion Groups

Welcome Reception in the Exhibit Hall


Stay on and attend Implementing RBM - Part 2: Effective and Efficient Monitoring
Keynotes | Monday Short Courses | Speaker Biographies


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SCOPE 2015 Wrap-Up

Held February 24-26, 2015, in Orlando, Florida, the 6th Annual SCOPE Summit gathered more than 900 industry leaders, an attendance increase of 30% from 2014, for three stimulating days of in-depth discussions covering important issues in clinical trial planning and management. With 12 different conference tracks, a Clinical Informatics News Best Practices Awards and three 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, Patient Engagement, Recruitment and Retention, Mobile Tech, Project Management, Forecasting, Quality (QbD) in Trial Conduct, Risk-Based Monitoring, Post-Marketing Studies, and Pharmacovigilance. 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 (24%), CRO (31%), and Biotech companies (20%). Industry leaders and key decision makers representing 13 different countries and more than 360 unique organizations shared case studies, collaborated on best practices and provided unique perspectives on poignant issues that the field currently faces.

For Further Information

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

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Preliminary Agenda Available!

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