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

BUILDING A COMPANY-WIDE RBM PLATFORM

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

HOW TO APPLY RBM: CASE STUDIES AND OPINIONS

Risk-Based Monitoring on Clinical Trials in Japan

Ritsuko Ashby, Central Monitoring Manager, Risk Management - Central Monitoring, The Janssen Pharmaceutical Companies of Johnson & Johnson

DATA VISUALIZATION AND ADVANCED ANALYTICS FOR RMB

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

MAKING VIRTUAL TRIAL REAL

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

PLENARY KEYNOTES

Tuesday Evening, Wednesday Morning, Wednesday Afternoon Plenary Keynotes Featuring:

SCOPE’s 2020 Participant Engagement Award, in Memory of Jerry Matczak
Patient Perspectives as an Input to Feasibility and Clinical Trial Design
Digital Trends that Are Changing Clinical Research
Health Literacy Throughout Drug Development – Why It Matters to Pharma and to Patients
Implementing an Innovation Methodology to Accelerate Clinical Trial Innovation within Your Organization

For more details on the Plenary Keynotes: www.scopesummit.com/keynotes
For more details on the Participant Engagement Award: www.scopesummit.com/participant-engagement-award

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 key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion at hand. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions below. To get the most out of this interactive session and 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: www.scopesummit.com/breakouts



For more details on the conference, please contact:

Marina Fishtinsky, MD

Executive Director, Conferences

Cambridge Healthtech Institute

Phone: (+1) 781.972.5496

Email: mfilshtinsky@healthtech.com

 

For partnering and sponsorship information, please contact:

Companies A-K

Ilana Quigley

Senior Manager, Business Development

Cambridge Healthtech Institute (CHI)

Phone: (+1) 781.972.5457

Email: iquigley@healthtech.com

 

Companies L-Z

Patty Rose
Senior Manager, Business Development

Cambridge Healthtech Institute (CHI)

Phone: (+1) 781.972.1349
Email: prose@healthtech.com