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.

PROTOCOL DEVIATIONS

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

ASSESSING QUALITY IN RBM AND CENTRALIZED MONITORING

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

RBM CASE STUDIES

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

Leveraging RBM & Centralized Monitoring Data for Site Insights

Nurcan Coskun, PhD, Global Risk Based Monitoring Program and Technology Solutions Manager, Medtronic


PLENARY KEYNOTE PRESENTATIONS ON TUESDAY AND WEDNESDAY
& CLINICAL RESEARCH NEWS EUROPEAN INNOVATIONS AWARDS

Clinical Research News European Innovations Awards

Clinical Research News' European Innovation Awards recognizes outstanding examples of applied strategic innovation—partnerships, deployments, and collaborations—that manifestly improve the clinical trial process. Submit your work: http://www.clinicalinformaticsnews.com/BestPracticeAwards/

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.

This year due to positive feedback we will be running two breakout discussion sessions, one on Tuesday afternoon and a second on Wednesday afternoon. Attendees will thus have a chance to join two topic discussions.

We are developing the breakout discussion topics now and are open to suggestions! Please see details at: https://www.scopesummiteurope.com/breakout-discussions



For questions or suggestions about the meeting, please contact:
Lee Yuan
Director, Conferences
Cambridge Healthtech Institute (CHI)
Phone: (+1) 781.972.5404
Email: lyuan@cambridgeinnovationinstitute.com

For partnering and sponsorship information, please contact:

Companies A-K:
Ilana Quigley
Sr. Manager, Business Development
Cambridge Healthtech Institute (CHI)
Phone: (+1) 781.972.5457
Email: iquigley@healthtech.com

Companies L-Z:
Patty Rose
Sr. Manager, Business Development
Cambridge Healthtech Institute (CHI)
Phone: (+1) 781.972.1349
Email: prose@healthtech.com

For media and association partnerships, please contact:
Rich Handy
Senior Director, Marketing
Cambridge Healthtech Institute (CHI)
Phone: (+1) 781.972.5456
Email: rhandy@healthtech.com