Cambridge Healthtech Institute’s 6th Annual
Implementing Risk-Based Monitoring – Part 2
Strategy, Data and Technology Solutions for RBM
February 20-21, 2020
Risk-based monitoring (RBM) approaches promise to improve clinical trial efficiency while ensuring data quality. As industry adoption of RBM increases, it is critical to reflect on lessons learned to refine the process, as well as focus on leveraging
RBM data for clinical operations. CHI’s 6th Annual Implementing Risk-Based Monitoring – Part 2 conference offers case studies and practical solutions from across pharma on effectively implementing clinical quality and RBM, as well as a
prospective look into the future of RBM.
Arrive early and attend Part 1 (Wed - Thurs): Implementing Risk-Based Monitoring – Part 1
Preliminary Agenda
The (R)evolution of Risk-Based Monitoring: A Tale of Two Deployments
Michael Walega, Head, Global Data Management & Centralized Monitoring, Bristol-Myers Squibb
How ARBM Builds Site Relationships, Connects Study Teams and Leads to Increased Efficiencies in Quality Deliverables
Joi Jenkins, Central Monitoring Manager, Integrated Data Analytics and Reporting, Global Clinical Development Operations, The Janssen Pharmaceutical Companies of Johnson & Johnson
Risk-Based Monitoring on Clinical Trials in Japan
Ritsuko Ashby, Central Monitoring Manager, Risk Management - Central Monitoring, The Janssen Pharmaceutical Companies of Johnson & Johnson
Risk-Based Monitoring: A Joint Focus on Meaningful Risk Signal Detection and a Process for Action
Erin Reynolds, Manager, Clinical Analytics, Data and Statistical Science, Research & Development, Abbvie
Building an eTrial
Laura Whitmore, Head, Clinical Operations, Oversight, Cerevel Therapeutics
CO-PRESENTATION: Statistical Surveillance Build & Grow – Adding a New Layer to RBM at Janssen
Christine Mazzucco, Global Trial Manager, The Janssen Pharmaceutical Companies of Johnson & Johnson
Dolly Ugi, Manager, Central Statistical Surveillance, The Janssen Pharmaceutical Companies of Johnson & Johnson
The Connected Patient: A "One Stop Shop" for Trial Information and Data
Megan McBride, MPH, Associate Director, Janssen Clinical Innovation, GCDO, R&D, Janssen, The Pharmaceutical Companies of Johnson & Johnson
INTERACTIVE PANEL: Making Virtual Real: Taking Trials Forward
Moderator: Jane Myles, Head, Operational Intelligence and Innovation, Roche
Sharin Roth, Director, Clinical Pharmacology, Bioanalysis, Otsuka Pharmaceutical Companies
Bardia Akbari, PharmD, Senior Vice President, Clinical Operations, Science37
Munther Baara, Head of New Clinical Paradigm, Global Product Development GPD-BT Development, Pfizer Inc.
Arrive early and attend Part 1 (Wed - Thurs): Implementing Risk-Based Monitoring – Part 1