Cambridge Healthtech Institute's 2nd Annual 

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.

Final Agenda

Tuesday, 17 September

7:30 - 17:00 Registration Open

7:30 Morning Coffee


Opening Plenary Keynotes


10:00 Grand Opening Coffee Break in the Exhibit Hall

10:50 Chairperson’s Opening Remarks

Andy Lawton, Director & Consultant, Risk Based Approach Ltd.

10:55 Solving Key Protocol Deviation Challenges to Improve Data Quality

Catherine Stewart, PhD, PMP, Executive Director, Clinical Sciences, Protocol Deviations, Pfizer

Currently, clinical research sponsors and sites are working to interpret potentially confusing or misunderstood elements of the ICH E3 and the associated guidelines related to protocol deviations (PD). Based on input from sites, IRBs, as well as research sponsors themselves, the TransCelerate Protocol Deviations Initiative is creating a Protocol Deviation Management Toolkit and engaging health authorities on this topic with a goal of ultimately improving patient safety, reliability of study data, and data quality.

11:20 Protocol Deviations: The Issues that Matter

Johnson_PaulMichaelPaul Michael Johnson, MSHS, Director, Global Clinical Operations, Kiniksa

The discussion will be focused on a practical guide to implementing protocol deviation planning oversight and proactive management from protocol development to CSR and includes notes on pitfalls and resource burden of overzealous protocol deviation capture.

11:45 Risk-Based Everything?

Baumgart_AdamAdam Baumgart, Global Head, Quality, Training & Risk Management, AstraZeneca

AstraZeneca like many companies has been through a series of incarnations of RBM and this presentation will cover a short history of why and where we are. RBM has spilled into adjoining areas such as quality assurance and site selection, so where does it begin and end? How is Risk Based Quality Management impacting planning of programs and protocols? What are some of the risk trends AZ have observed and how is this changing the way we work?

Triumph_Research_Intelligence 12:10 What the FDA Pushing RBQM and E8 (R1) Means for Your Studies

Finnigan_TammyTammy Finnigan, COO, Operations, TRI

The FDA want us to “stop calling it Risk-Based Monitoring and call it Risk-Based Quality Management, it’s not just about monitoring, it is an end-to-end process”. Recent E8(R1) guidance greatly reinforces this approach. In this session Tammy will share what RBQM and E8(R1) means for your studies, how to become a champion for driving reform of risk management and how to use RBQM to deliver better clinical trials.

12:35 Lunch in the Exhibit Hall (Community Networking)

13:55 Chairperson’s Remarks

Andy Lawton, Director & Consultant, Risk Based Approach Ltd.

14:00 Quality Tolerance Limits: Achieving High Quality with a Tolerance for Imperfection

Bojarski_LukaszLukasz Bojarski, Associate Director, Central Monitoring, AstraZeneca Pharmaceuticals, Inc.

ICH GCP R2 and Transcelerate definitions of Quality Tolerance Limits (QTLs) will be discussed and key differences between QTLs, risk indicators and action thresholds will be presented. An approach to QTL set-up, both in terms of selection of a parameter and identification of a tolerance limit, will be proposed. Challenges to QTL implementation at scale and speed in AstraZeneca will also be discussed.

14:25 CO-PRESENTATION: The Quality Journey - A Small Company’s Approach to the Implementation of ICH E6 and RBM

Lawton_AndyAndy Lawton, Director & Consultant, Risk Based Approach Ltd.

Sun_YiwenYiwen Sun, Associate Manager, Clinical Risk Management at Samumed, LLC

This presentation will be in two parts, firstly examining the overall quality imperative within the clinical trial arena and the second part will focus on Samumed’s ICH E6 and RBM journey to current status and future direction. Key points: 1. Understand the quality requirement expected of sponsors, 2. What can be achieved by a small company – current status, 3. Future direction.

15:15 Speed Networking

Bring your business cards for networking with your peers in the session room!

15:30 Refreshment Break in the Exhibit Hall


16:10 Find Your Table and Meet Your Moderator

16:15 Interactive Breakout Discussion Groups (Session #1)

17:00 Networking Reception in the Exhibit Hall

18:00 End of Day

Wednesday, 18 September

8:00 Morning Coffee


8:30 Chairperson’s Remarks

Andy Lawton, Director & Consultant, Risk Based Approach Ltd.

8:35 Leveraging RBM & Centralized Monitoring Data for Site Insights

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

This presentation will discuss the methodically and process that we are using for analyzing the RBM and centralized monitoring data we have collected as well as provide examples of how we are leveraging the data to enhance our decision making around site selection and other site insights.

9:00 INTERACTIVE PANEL DISCUSSION: Measuring the Effectiveness of RBM


Marion Wolfs, Director, Risk Management-Central Monitoring, Janssen


Makowski_MarcinMarcin Makowski, Head, Risk Based Monitoring & Standards, UCB

Baumgart_AdamAdam Baumgart, Global Head, Quality, Training & Risk Management, AstraZeneca

Lawton_AndyAndy Lawton, Director & Consultant, Risk Based Approach Ltd.

Crona O’Conallain PhD, Senior Director, Head EMEA and Latin America, Centralised Monitoring Services, Clinical Operations, IQVIA

  • How should we define effective RBM? The definition of effective RBM should be linked to the purpose of RBM -> improve quality and create efficiencies
  • How do you measure improvement of quality due to implementation of RBM? (KRIs, QTLs, audit and inspection findings)
  • How do you measure efficiencies gained?
  • How do you deal with noise in measurements, created by other process improvements/changes to processes?
  • Who do you measure when RBM is considered business as usual?

9:50 Coffee Break in the Exhibit Hall


10:35 How Alkermes Created a Risk-Based Data Quality Oversight Framework

Amy Neubauer, Director, Data Quality Oversight, Alkermes, Inc.

Many CROs are offering RBM capabilities but how should sponsors provide oversight for outsourced studies? This session will take a look at the roles, tools, partnership model, internal framework, high level results, lessons learned, and future plans that Alkermes’ Clinical Data Sciences team is taking to lead the clinical study teams in an effective risk-based data quality oversight approach as the company transitions from small pharma to mid-sized.

11:05 Fit for Purpose RBM for Novel Study Types

van_Huijkelom_RyanneRyanne van Huijkelom, Manager, Risk Management-Central Monitoring, Janssen

Risk-Based Monitoring is commonly applied to later phase pharmaceutical studies with the goals of attaining subject safety, data quality, and operational efficiencies. However, the risk management requirements described in ICH-GCP E6 (R2) also apply to other types of clinical studies. Since Risk-Based Monitoring is flexible by design, it can be made fit for purpose and applied to all study types. We’ll explore how using the different steps of Risk-Based Monitoring in a flexible way at J&J, Risk-Based Monitoring has been implemented not only in later phase but also in novel study types.

11:35 Risk-Based Monitoring of Virtual Trials

Makowski_MarcinMarcin Makowski, Head, Risk Based Monitoring & Standards, UCB

Decentralized Trial (DCT) Model utilizes telemedicine to reach patients. The model creates many opportunities and a few specific challenges. The presentation will concentrate on the challenges around monitoring of such trials. Traditional on-site monitoring brings limited value. Moreover, classical risk-based monitoring concentrated on between-site differences also doesn’t fit as often there is just one site. A new model of monitoring implemented on one of UCB DCT's based on cooperation and division of responsibilities between the site, CRO, and the sponsor will be presented.

11:50 Q&A with Speakers

12:15 Lunch in the Exhibit Hall (Community Networking)

13:25 Transition to Breakouts & Keynotes


13:35 Find Your Table and Meet Your Moderator

13:40 Interactive Breakout Discussion Groups (Session #2)

14:10 Clinical Research News’ European Innovations Awards & Closing Plenary Keynotes

15:25 Close of Conference


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:


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.

Please see details at:

For questions or suggestions about the meeting, please contact:
Marina Filshtinsky, MD
Executive Director, Conferences
Cambridge Healthtech Institute (CHI)
Phone: (+1) 781.972.5496

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

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

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