Cambridge Healthtech Institute's
Risk-Based Monitoring Europe
Integrating Quality Into Clinical Trials To Ensure Effective Monitoring
17-18 September 2019
As industry adoption of risk-based monitoring increases, it is clear that although RBM takes many forms – remote, centralized, and risk-based monitoring – successful risk-based monitoring implementation from pilot studies to full-scale rollout
requires a foundation of quality, appropriate processes, and analytics. CHI's Risk-Based Monitoring Europe conference focuses on implementation case studies (especially in different study designs), practical solutions to RBM rollout,
and a prospective look into the future of RBM.
The gathering will be part of the Summit for Clinical Trials Operations Executives (SCOPE) Europe, a two-day event made up of shared plenary keynotes from biopharma thought leaders, five conference tracks focused on specific issues and functions within
the clin ops, innovation and research enterprise, informal and interactive breakout discussion groups, and networking.
Keynotes | Track 1-Feasibility | Track 2-Engagement | Track 3-Monitoring | Track 4-Digitalization | Track 5-Budgeting
Solving Key Protocol Deviation Challenges to Improve Data Quality
Catherine Stewart, PHD, PMP, Executive Director, Clinical Sciences, Protocol Deviations, Pfizer
Protocol Deviations: The Issues that Matter
Paul Michael Johnson, MSHS, Director, Global Clinical Operations, Kiniksa
Aligning Expectations of Quality Monitoring
Michael Walega, MS, Head, Centralized Monitoring, Global Data Management and Centralized Monitoring, Bristol-Myers Squibb
Quality Tolerance Limits: Achieving High Quality with a Tolerance for Imperfection
Lukasz Bojarski, Associate Director, Central Monitoring, AstraZeneca Pharmaceuticals Inc
CO-PRESENTATION: The Quality Journey - A Small Company's Approach to the Implementation of ICH E6 and RBM
Andy Lawton, Director & Consultant, Risk Based Approach Ltd.
Yiwen Sun, Associate Manager, Clinical Risk Management at Samumed, LLC
Case Study: How Alkermes Created a Risk-Based Data Quality Oversight Framework
Amy Neubauer, Director, Data Quality Oversight, Alkermes, Inc.
Fit for Purpose RBM for Novel Study Types
Ryanne van Huijkelom, Manager, Risk Management-Central Monitoring, Janssen
Risk-Based Monitoring of Virtual Trials
Marcin Makowski, Head, Risk Based Monitoring & Standards, UCB
Leveraging RBM & Centralized Monitoring Data for Site Insights
Nurcan Coskun, PhD, Global Risk Based Monitoring Program and Technology Solutions Manager, Medtronic