Original Agenda
We are actively working with our speakers to confirm their availability for our new dates. Initial response from our speakers has been very positive, and we are optimistic we will have the new programs ready to share here soon.

Cambridge Healthtech Institute’s 4th Annual

Risk-Based Quality Management and Monitoring

Beyond COVID-19: Tools and Processes to Accelerate RBQM and Improve Monitoring

20 - 21 April 2022 CET

Where RBQM implementation had proceeded in a conservative, iterative manner pre-pandemic, but the challenges presented during this unexpected crisis have resulted in acceleration of RBQM adoption and on-site and remote monitoring practices in clinical trials. With the backdrop of lessons from COVID-19, CHI’s 4th Annual Risk-Based Quality Management and Monitoring conference provides processes and tools for acceleration of RBQM implementation, regulatory requirements, QTL & KRI setup and monitoring, early risk and issue detection, and monitoring approaches. 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, 4 conference tracks focused on specific issues and functions within the clin ops, innovation and research enterprise, informal and interactive breakout discussion groups, and networking. Please join us at this year's "Risk-Based Quality Management and Monitoring" conference at SCOPE Europe, a hybrid conference in 2021serving both in-person and virtual attendees.

Tuesday, 5 October

07:30 Registration and Morning Coffee


08:50 Welcome by Conference Organizer

Bridget Kotelly, Senior Conference Producer, Cambridge Healthtech Institute (CHI)


Chairperson's Remarks

Marcin Makowski, PhD, Head, Centralized Monitoring & Data Analytics, GlaxoSmithKline

Pivoting to Patient-Centric Trial Design: Risk-Based Management of Decentralized Clinical Trials

Kavita Rattan, PhD, Lead, AI-Data Sciences & RBM, Data Monitoring & Management, Pfizer Inc.

Decentralized clinical trials (DCTs) offer multiple benefits including enhanced patient experience, high quality data and the agility to manage disruptions, e.g. COVID19 pandemic. Implementing an effective decentralized solution requires a robust RBQM process that allows early identification of risk and centralized monitoring can be a key component of a decentralized design to inform timely decision making. This presentation will discuss case studies and risk analytics for successful management of DCTs.


RBQM Execution in Full-Service Outsourcing Models

Marcin Makowski, PhD, Head, Centralized Monitoring & Data Analytics, GlaxoSmithKline

Sponsor organizations must oversee the execution of trials when those are outsourced to CROs. This includes oversight of risk-based quality management strategies. This may be somewhat challenging in full-service outsourcing models when CROs are using their own procedures, tools, and processes. The presentation will include key risks to RBQM planning and execution in outsourced models and oversight model that may be applied to mitigate the risks. 

Speaker to be Announced

Implementation of Central Monitoring: Guiding Principles for Widespread Adoption and Maximum ROI

Nicole Stansbury, Vice President, Global Centralized Monitoring, Global Centralized Monitoring, Syneos Health

Central Monitoring has been encouraged since ICH E6 (R2) in 2016, but adoption has been slower than anticipated.  Obstacles to implementation include access to data, data format and standards, cost and complexity of analytical tools to visualize data, integration into clinical monitoring process, where in the organizational structure central monitoring is best aligned and what skillsets are needed for those primarily responsible for conducting the analyses.  Establishing a few guiding principles can help overcome these challenges resulting in greater adoption and successful return on investments.  This session will explore one organization’s strategy and lessons learned.  

11:00 Exhibit Hall Viewing



Chairperson's Remarks

Nick Carroll, PhD, Transformation Lead, Digital Health, R&D, AstraZeneca

FIRESIDE CHAT: Combining Innovation and Collaboration to Advance Research across the Industry...We Can’t Do It Alone​

Sam Hariry, Global Head, Clinical Innovation, Novartis Institutes for Biomedical Research
Lewis Millen, Operations Innovation Lead, Global Clinical Sciences & Dev Solutions, UCB Pharma

The biopharma, medical device, digital medicine, healthcare and tech industries involved in clinical research are learning from one another, improving innovation, re-thinking business process, and expanding what used to be a much more siloed ecosystem. These are exciting times, but it is a very complex garden to navigate. How do we continue to innovate beyond pilots? How do we scale innovation and collaborate across departments, companies and industries to improve clinical trials and research?


What Could Digital Transformation of an Entire Biopharma Company Look Like?

Francesca Wuttke, PhD, Chief Digital Officer, Almirall SA

Biopharma companies are trying to change business processes, drug discovery, manufacturing, clinical trials…their entire cultures, to provide more digital solutions and services to their customers but it’s a long road. What are the main impediments to adoption? How can companies do different things (digitally enabled business models) rather than just do things differently (digitization)? Where can companies find the best chance of success and how do they start? How can large pharma, biotech, specialty pharma and traditional life sci organizations transition?


Digital Health in the Circular Economy, Novel Partnerships Required

Bert Hartog, PhD, Senior Director Clinical Innovation, Janssen Pharmaceutica NV

The talk will be about the environmental impact of digital health, and how circular economy principles can help minimize eWaste and maximize repurposing, reuse and recycling of digital health technologies.


What Can Clinical Innovation Teams Learn from Digital Health Startups?

Panel Moderator:
Francesca Wuttke, PhD, Chief Digital Officer, Almirall SA

Working with startups can provide the Pharma industry with the innovation capabilities required to accelerate the digital transformation of the company, while embedding a culture of experimentation where there is freedom to try and fail, through the exposure to and collaboration with young and risk-taking startups. Partnering with Startups offers Pharma access to solution-driven technology which allows them to accelerate their growth and drive strategy.

Andrea Coravos, CEO & Co-Founder, HumanFirst
Bert Hartog, PhD, Senior Director Clinical Innovation, Janssen Pharmaceutica NV
Nader Alaghband, Co-Founder & CEO, Ampersand Health
13:20 Enjoy Lunch on Your Own
14:20 Exhibit Hall Viewing



Chairperson's Remarks

Marcin Makowski, PhD, Head, Centralized Monitoring & Data Analytics, GlaxoSmithKline

GCP Renovation: The Impact of ICH E8 and ICH E6 Revision

Kerstin Koenig, PhD, Vice President, Global Head Research & Development Quality, Bristol-Myers Squibb
Rebecca Stanbrook, Executive Director, Development and Regulatory Policy, Novartis

January 2017 saw the publication of the reflection paper from ICH on GCP Renovation.  The single largest update to ICH guidelines surrounding clinical trials.  The first of these for revision was ICH E8 and the renovation of E6 started sometime later in 2019.  With the release of the final text for E8 and the publication of draft principles of E6 for information, this is an excellent time to hear from the 2 EFPIA topic leads on these important guidelines.  This presentation will cover the background to the renovation efforts, provide a review of ICH E8, and an update on the current progress of E6?.


MSD's Risk-Based Approach to Protocol Deviation Processes

Laura Galuchie, TransCelerate Program Lead, Oversight Committee, MSD


Striving to do high quality work is a good trait, especially for clinical trials. MSD will share a story from the past, how they got SMART and why they now focus on what matters by embracing a risk-based approach to the management of protocol deviations.

Speaker to be Announced
16:25 Interactive Discussions

Interactive Discussions are informal, moderated discussions, allowing participants to exchange ideas and experiences and develop future collaborations around a focused topic. Each discussion will be led by a facilitator who keeps the discussion on track and the group engaged. For in-person events, the facilitator will lead from the front of the room while attendees remain seated to promote social distancing. For virtual attendees, the format will be in a Zoom room. To get the most out of this format, please come prepared to share examples from your work, be a part of a collective, problem-solving session, and participate in active idea sharing. Please visit the Interactive Discussions Page on the conference website for a complete listing of topics and descriptions. 

17:05 SCOPE Europe Connects Exhibit Hall Viewing
18:00 Close of Day

Wednesday, 6 October

08:30 Registration and Morning Coffee



Chairperson's Remarks

Marta Arias-Salgado Ruiz-Gimenez, Head of Quality & Continuous Improvement, Global Clinical Trials Organization, MSD

New Frontiers in Risk-Based Quality Management: From Simulation to Practice

Andrzej Kinasiewicz, PhD, Team Manager, Centralized Monitoring, Site Quality Risk Management, AstraZeneca
Jakub Tyszecki, Associate Director, Centralized Monitoring, AstraZeneca

Current applications of RBM across the industry focus on reducing expenditures associated with onsite monitoring. Nowadays, pharma is still dealing with reduction of SDV, which has been confirmed as bringing extremely limited value. We look to demonstrate there is room for further significant reductions in site monitoring. By applying Bayesian Network Monte Carlo simulations we model detrimental site behaviours and evaluate their impact on overall study quality.


The Monitoring Process Changed: How Do You Know It's Working?

Keith Dorricott, Ambassador, Metrics Champion Consortium

Your monitoring process includes a combination of centralized, remote and onsite monitoring of your clinical trials. Have you updated the metrics that you are using to oversee the new integrated process? Are you using the right KRIs? Are identified risks turning out to be actual issues? Are your monitors focusing on the most important risks and issues? Are site issues being addressed? These are questions that a multi-stakeholder group has been exploring at an industry consortium. Find out about the approach, the challenges, and some of the new monitoring metrics developed by the group.

10:05 Sponsored Presentation (Opportunity Available)



Special Catalan Ecosystem Panel: Digital Transformation and Clinical trials: The Next Challenge in Health

Panel Moderator:
Montse Daban, Director, Scientific and International Relations, Biocat

The healthcare community agrees on the need to foster digital transformation throughout the entire healthcare value chain, including the framework for the clinical validation of innovative technologies, i.e., the evidence for real-world positive and significant health outcomes for patients and society. The final objective is to accelerate technology adoption, provide support for the validated ideas, and improve their market access. The session will share perspectives of actors connecting clinical research and industry in a comprehensive way and it will highlight the successful coordination in clinical trials key stakeholders in Catalonia.

Montserrat Barcelo Riera, MD, Vice President, Europe, Veristat
Xavier Cañas, Director, Promotion and Development of Clinical Research, Vall d’Hebron Hospital
Dani Prieto-Alhambra, MD, PhD, Professor, Pharmaco- and Device Epidemiology, University of Oxford
Lidia Cánovas, General Manager, Regulatory Affairs, Asphalion
11:05 Exhibit Hall Viewing



Chairperson's Remarks

Karl-Ludwig Radek, Assistant Director, Global Clinical Operations & Janssen Internal Project Lead for IMI Trials@Home

Harnessing the Power of Real-World Data for Clinical Research: European Initiatives

Dipak Kalra, PhD, President, European Institute for Health Records & President, European Institute for Innovation through Health Data

Real World Data has historically been regarded as siloed within healthcare provider systems (and therefore fragmented, difficult to access at scale), with patchy coverage and often of poor quality - so not very reliable for research. A further barrier is data protection legislation, in Europe with the GDPR. Large-scale research infrastructure initiatives are now being established across Europe to tackle these issues and to make RWD more available for observational data studies and the reuse of EHRs for clinical trials. This talk will present this exciting landscape, including the Commission proposals for a European Health Data Space, and explain how some of the perceived issues with RWD are being tackled, including winning public support for the use of RWD by industry.


Hybrid and Decentralized Trials: The Future Is Here

Panel Moderator:
Karl-Ludwig Radek, Assistant Director, Global Clinical Operations & Janssen Internal Project Lead for IMI Trials@Home

Covid-19 has played an extreme catalyst role in implementing existing digital and remote clinical trial solutions and has been the engine behind rapid evolution of a few new capabilities. Some of these newly deployed capabilities are quick fixes for the emergency that COVID brought to our day-to-day trial operations, while many will benefit from the catalyst effect and will probably be the new standard even after COVID. Today, we have the chance to continue driving adoption of decentralized clinical trials – and innovating to advance the benefits DCTs offer to patients, sites and sponsors.

Dipak Kalra, PhD, President, European Institute for Health Records & President, European Institute for Innovation through Health Data
Cristina De Juan, PhD, Innovation Lead, Global Clinical Sciences and Operations (GCSO), UCB
Xia Wang, PhD, Director, Healthcare and Imaging Analytics, Data Science & AI, R&D, AstraZeneca Pharmaceuticals LP
Marta Arias-Salgado Ruiz-Gimenez, Head of Quality & Continuous Improvement, Global Clinical Trials Organization, MSD
Kavita Rattan, PhD, Lead, AI-Data Sciences & RBM, Data Monitoring & Management, Pfizer Inc.
12:55 Enjoy Lunch on Your Own
13:55 Exhibit Hall Viewing



Chairperson's Remarks

Marta Arias-Salgado Ruiz-Gimenez, Head of Quality & Continuous Improvement, Global Clinical Trials Organization, MSD

Evolution of Clinical Investigator Site Audits as a Result of the Pandemic

Nuria Gomez Mas, GCP Auditor, EMEA, Janssen

The global pandemic challenged us all to think outside of the box. The pandemic has offered auditors a way to adapt successfully and to evolve our methodologies. Through innovative thinking and increased use of technology, we have taken audits from onsite to a more virtual approach. A remote audit ensures involvement with investigational site staff with key source data review while a Hybrid audit includes a limited onsite portion with the involvement of an eyes and ears role. This evolution has shown the delivery of high-quality audits that will offer sustainable options for audit conduct now and for the future.

15:00 Sponsored Presentation (Opportunity Available)

Case Study: Solving for the Challenges of Unblinded Monitoring in Double Blind Studies

Marta Arias-Salgado Ruiz-Gimenez, Head of Quality & Continuous Improvement, Global Clinical Trials Organization, MSD

Many sponsors face important operational challenges when they  split monitoring in blind and unblinded roles. You need two teams  with the impact on cost and resources but you also increase the operational risk of unblinding the blind team. Your systems may not be ready to build a firewall. Human error plays a role too and suddenly you end up managing several quality issues related to unintentional unblinding. After attempts of  adjusting  processes, MSD rolled out a new innovative and flexible  operating model in collaboration with a CRO partner, enabling us full oversight and control, minimizing the risks.

Speaker to be Announced

Data-Driven Sponsor Oversight of Outsourced RBM

Wim Nijhoff, Director & Senior Clinical Quality Management Lead, EMD Serono

RBM is now incorporated as a GCP expectation in most ICH regions and  by regulatory agencies. Sponsors are accountable to ensure proper oversight of the execution when activities are outsourced to CROs. In addition, the COVID-19 pandemic showed the importance of centralized, data-driven sponsor oversight to ensure patient safety and high-quality clinical trial data. This session will explore Merck KGaA’s strategy on sponsor oversight.

16:30 Closing Remarks

Bridget Kotelly, Senior Conference Producer, Cambridge Innovation Institute

16:35 Close of Conference