Risk-Based Quality Management and Monitoring
（リスクベースの品質管理とモニタリング）
COVID-19を超えて： RBQMを加速させ、モニタリングを改善するためのツールとプロセス
2023年10月17日〜18日
10月16日（月）
- 18:30 Innovation Day at SCOPE Europe with IQVIA Technologies14:30
Join IQVIA Technologies’ digital product leaders and customer success experts for an afternoon of discussions and demos. We’ll share our vision to transform clinical operations, the progress we’ve made to date, and our roadmap for 2023 and beyond.
10月17日（火）
Registration and Morning Coffee07:45
RBQM IN A CHANGING CLINICAL TRIALS LANDSCAPE: REGULATORY UPDATE, DCT, AND HYBRID TRIALS
変化する臨床試験情勢におけるRBQM: 規制の更新、分散型臨床試験、およびハイブリッド治験
The Renovation of ICH Good Clinical Practice - TransCelerate Framework for ICH E8
Christine Goffe, Team Lead, Study Data Risk Manager, Risk Management & Data Quality, UCB SA
The updates of ICH E8 and E6 represent a shift in the conduct of clinical research from a one-size-fits-all to a risk-based approach. TransCelerate framework focuses on elements identified as essential for successful implementation for ICH E8 as the foundation for the revisions to E6. This session will demonstrate the change of perspective and ways of implementing the GCP renovation, focusing on Designing Quality into Clinical Studies, Culture, and Engagement.
Considering Common Audit Findings in Your RBQM Strategy and Monitoring Activities
Katarina Thor, Vice President, Clinical Quality & Compliance, R&D Quality, Novo Nordisk
RBQM and monitoring audit findings typically involve evaluation of the effectiveness of the RBQM strategy and the quality of the monitoring activities carried out during a clinical trial. Addressing these audit findings can help to improve the quality of the trial, and ensure the safety and well-being of trial participants. Explore some common areas of potential risk identified during audits, and recommendations for improving the RBQM strategy and monitoring plan.
Leveraging Predictive Analytics to Improve Patient Retention, Data Quality, and Enrollment Outcomes in Clinical Trials
Rohit Nambisan, Co-Founder and CEO, Lokavant
Clinical trial data complexity has tripled in the past decade, leading to fragmented data, insights, and stakeholder collaboration. These complexities pose significant inefficiencies in the research and drug development process and are exacerbated as clinical operations teams become leaner and cost-constrained. In this presentation, you will gain insight into real-world case studies using Lokavant to radically improve clinical trial outcomes, as well as overall successes for leaner study teams.
RBQM for Decentralized and Hybrid Trials
Lukasz Bojarski, Executive Director, Centralized Monitoring & Risk Based Quality Management, AstraZeneca
Following recent release of FDA's new draft guidance, that provides recommendations for sponsors, investigators, and other stakeholders regarding the implementation of Decentralized Clinical Trials (DCT), we will discuss considerations for applying Risk-Based Quality Management to prioritize quality management activities with the aim to ensure proper oversight of decentralized and hybrid trials.
Sponsored Presentation (Opportunity Available)10:40
Grand Opening Coffee Break in the Exhibit Hall10:53
OPENING KEYNOTE: CLIN OPS AS A GROWTH DRIVER & EU TRANSPARENCY REGS & GLOBAL DCT ADOPTION THROUGH COLLABORATION
オープニング基調講演：成長の原動力としての臨床業務、欧州の透明性規制、協業による世界の分散型臨床試験の導入
Clinical Ops as a Growth Driver
Deirdre BeVard, Senior Vice President, R&D Strategic Operations, CSL Behring GmbH
Clinical Operations is the hardest job you'll ever love. It drives the growth of a clinical development portfolio that results in new therapeutic options for the patients who need them. This awesome responsibility may look "easy" from the outside, but starting and managing a clinical trial is like launching a new business into a saturated market each and every time. Let's talk about how inspiring you are!
Returning Results to Patients: Not Just a Regulatory Requirement with a Grace Period
Kimbra Edwards, PhD, Senior Director, Health Communication Services, Center for Information and Study on Clinical Research Participation (CISCRP)
EU Regulation/2014/536 requires results from trials initiated after January 2022 to be shared publicly within a year of completion and yet some sponsors are not sharing results. Several EU countries have successfully turned up the heat on sponsors who haven't shared the findings of their clinical trials actively pushing negligent sponsors and investigators to publicly share the results of past trials, an enforcement practice that's picked up momentum. After attending this presentation, the audience will: recognize the importance of returning trial results, in plain language, to all trial participants; describe the ramifications of not submitting plain language results; and plan for a large-scale implementation plan for returning results.
Navigating Global DCT Adoption: Driving Change through Collaboration
Craig Lipset, Founder, Advisor, Clinical Innovation Partners; Co-Chair, Decentralized Trials & Research Alliance (DTRA)
Global clinical trial teams are increasingly interested in using decentralized trial (DCT) methods. DCT technology and services providers have created a large variety of solutions for trial teams to use. However, there is no curated ‘source of truth’ accessible for providers or trial teams to understand which solutions can be used in which countries. The DTRA Regulatory Conduct Map initiative team has been focused on addressing this gap as part of its initial priorities to support the adoption of DCTs globally. In this session, initiative team members will share their approach to solving this challenge and how to use the deliverable they’ve created. Panelists will also share case studies on the application of this tool, and how it’s helping drive understanding and adoption of DCTs globally.
Join Your Peers for a Networking Luncheon in the Exhibit Hall13:00
CASE STUDIES IMPLEMENTING AND EVOLVING RBQM
RBQMの実行と進化のケーススタディ
Evolution or Revolution? MSD’s Journey in the Expansion of End-to-End RBQM Concepts: Where We Are, What We’ve Learned So Far, and Where We’re Heading
Greg Cinciala, Director, Risk Evaluation & Adaptive Integrated Monitoring, Clinical Trials, MSD
Implementing RBQM principles into an existing Clinical Trial ecosystem is disruptive. But is this an evolution or revolution of how clinical trials are managed? We will share our journey of implementation and evolution of RBQM model and what we’re learning when it comes to designing RBQM components (Risks, Indicators, QTLs, and Central Analytics). And last - what is ahead of us and what other opportunities we see in the future?
The Vision of Future System Utilization with Risk-Based Quality Management: Strategies, Challenges, and Success Stories
Capability Failure = Study Failure: How to Prevent Both
Clinical studies play a crucial role in advancing medical knowledge and improving patient care. However, failures attributed to competency gaps among clinical research staff have become a significant concern. Inadequate training and experience may lead to false positive and false negative study results, impacting both patient outcomes and research integrity. The session reflects on the implications of competency gaps in clinical research, emphasizing the need for comprehensive training programs to enhance staff skills, and ensure reliable study outcomes. Addressing these gaps is vital for maintaining the credibility and effectiveness of clinical trials.
How RBQM Can Become the Connective Tissue for Data Quality
Sponsored Presentation (Opportunity Available)16:20
Change Management: The People Component Can Make or Break Your RBQM Program
Keith Dorricott, Director, Dorricott Metrics & Process Improvement Ltd.
People, process, and technology all need to work together for an effective RBQM program. But the people component can be one of the most challenging - whether it is the culture change needed in moving to risk-based approaches or the specific knowledge and skills to implement and run RBQM processes across different study types and teams within an organization. What can be developed in-house? What should come in from outside your organization? How do you help your people think critically as described in ICH E8 R1? Our panel of RBQM practitioners will discuss the people component, the challenges, and the approaches they have used to overcome those challenges.
Welcome Reception in the Exhibit Hall with Beer, Wine, and Tapas16:57
Close of Day18:00
10月18日（水）
Registration and Morning Coffee08:15
RISK-BASED APPROACHES, DATA STRATEGY, AND MONITORING
リスクベースのアプローチ、データ戦略、およびモニタリング
Intersection of Risk-Based Quality Management and Clinical Data Sciences of the Future
Lynne Cesario, Executive Director, Global Lead Risk Based Monitoring Program, Pfizer Global R&D Groton Labs
This presentation will explore how advanced technology solutions and AI/ML are being leveraged to manage and monitor the ever-expanding volume and complexity of data being captured.
Making RBQM Simple for All Clinical Trials-Duncan-Hall-25-Minute-Presentation.jpg)
Medical Review Focused on Critical Data: Is the Centralized Medical Review Team the Answer?
Malgorzata Wegner-Patera, Senior Director, Clinical Trial Safety, AstraZeneca Pharma Poland Sp. z o.o.
A centralized data review team ensures standardized, systematic medical data review focused on critical data and complex checks, complementing centralized monitoring signal detection. This model shifts clinical data review, including about 50% of EDC modules, to a centralized function, enabling efficient data flow from the first subject to close-out. The cross-functional review framework and automation tools, including listings, dashboards, and patient profiles, improve quality and performance. This agile framework with medical oversight protects the safety of study participants and ensures scientific data value.
Sponsored Presentation (Opportunity Available)10:05
Coffee Break in the Exhibit Hall and Special Book Signing10:17
Digital Health and Patient Data: Empowering Patients in the Healthcare Ecosystem
Authors:
Disa Lee Choun, Head of Integrated Clinical and Operational Analytics, Janssen
Anca Petre, PhD, Co-Founder, 23 Consulting
MORNING KEYNOTE: MOVING eCOA, ePRO, e-SOURCE, EDC, AND ANY OTHER "e" INTO REALITY IN A DIGITAL HEALTH WORLD
モーニング基調講演：デジタルヘルスの世界におけるeCOA、ePRO、e-SOURCE、EDC、その他のあらゆる“e”の現実への移行
eCOA- and ePRO-Centricity in a Digital Health World
Lisa Henderson, Editorial Director, Applied Clinical Trials
As digital health technologies make strides in collecting objective data from patients remotely, how does ePRO and other eCOAs fit within a holistic, patient-centered approach to quality data collection in clinical trials? This panel will discuss the importance of and differences among digital endpoints, digital biomarkers, and eCOA/ePRO.
From Concept to Reality - The eSource-to-EDC Revolution Gathers Pace
Mats Sundgren, PhD, Senior Industry Scientific Director, i-HD (European Institute for Innovation through Health Data)
The eSource data captured daily in hospitals’ EHRs is increasingly gaining traction within the clinical research community as the basis of a powerful opportunity to transform the way clinical trials are run. This session discusses the potential and the challenges of direct transfer of clinically-validated data from EHR-to-EDC: Is there now a common impetus for investment in data quality by sites and sponsors? Can advances in technology deliver flexible and scalable solutions for EHR-to-EDC data transfer?
Join Your Peers for a Networking Luncheon in the Exhibit Hall12:00
E2E RBQM: LEVERAGING RISK-BASED APPROACHES IN ALL ASPECTS OF CLIN OPS
E2E RBQM：臨床業務のあらゆる側面におけるリスクベースのアプローチの活用
Vendor Oversight via Modern Risk Management Techniques
Natalia Buchneva, Risk Management Lead, Clinical Data & Innovation, UCB
In this session, we will discuss scenarios about how to strengthen the clinical vendor oversight using Risk Management system(s) and tools at the stage of vendor selection, risk assessment, defining the tailored oversight model, and using the dashboards which can help monitor the performance of the vendors in clinical trial.
Securing Patients' Compliance: Case Study of RbQM Application in ePRO Primary Endpoint Clinical Trial
ePRO instruments are used to support labeling claims and measure long-term treatment benefits in clinical trials. Deterioration of patients ePRO compliance over time may impair the Sponsor’s ability to collect primary or key secondary endpoint data. Large amount of missing data may impact reliability and interpretability of the clinical trial results. Risk identification, real-time monitoring and early detection of potential systematic issues play a key role in delivery. Based on a case study, we discuss the advantages of Risk-based Quality Management methodology implementation and the role of centralized monitoring in proactive and effective control of defect rates in the clinical trial.
Sponsored Presentation (Opportunity Available)14:50
Session Break15:15
CLOSING KEYNOTE: CLINICAL RESEARCH NEWS, SCOPE BEST OF SHOW AWARDS 2023, TECH TO ENABLE PATIENT-CENTRIC TRIALS & BUILDING SUCCESSFUL OUTSOURCING PARTNERSHIPS
クロージング基調講演：臨床研究ニュース、SCOPE BEST OF SHOW AWARDS 2023、患者中心の臨床試験を可能にする技術、成功するアウトソーシングパートナーシップの構築
Clinical Research News' Best of Show Award: Recognizing Exceptional Innovation in Technologies Used by Clinical Research Professionals (Sponsored by Clinical Research News & ClinEco)
Allison Proffitt, Editorial Director, Bio-IT World
The 2023 Best of Show Awards offer exhibitors of the SCOPE Summit Europe an exclusive opportunity to distinguish and highlight their products, ranging from an innovative application, technology, tool, or solution. The SCOPE community is invited to identify exceptional innovation in technologies used by life science professionals, voting on most impactful new products of the year. Exhibitors are invited to enter your products via the online submission form below. Attendees are encouraged to explore the novel technologies and solutions firsthand in the exhibit hall and vote for the People's Choice Award once the conference has begun. Submit your entry!
https://www.scopesummiteurope.com/sponsor-exhibitor/best-of-show-awards
CASE STUDY: Patient-Centric Sampling Solutions in Action
Chiara Rospo, Bioanalytical Scientific Manager Development Science, Translational Biomarkers & Bioanalysis, UCB Pharma SA
Real case studies of implementation of a patient-centric sampling solution at UCB will be discussed, highlighting the complexity and the skills required to be successful. Tips on overcoming challenges will be shared.
Patient-Centric Blood Sampling as an Enabler for Decentralised Clinical Trials
Neil Spooner, PhD, Co-Founder and Chair, Patient Centric Sampling Interest Group (PCSIG)
In order to fully realise the potential for enhancing patient recruitment and retention for DCTs, the impact of blood sample collection for the determination of pharmacokinetics, measurement of biomarkers, and clinical chemistry also needs to be considered. This interactive panel will introduce you to technologies and workflows that enable the collection of these samples in the patients home, either by self-sampling, or by a caregiver, thus increasing patient choice and engagement. By attending this session you will learn: What PCS is; What the potential benefits are when incorporating patient friendly blood sampling into DCTs; Practical considerations on how to implement into your DCTs.
Unlocking the Crucial Ingredients for a Successful Outsourcing Partnership: Time to Challenge the Status Quo and Focus on Value-Based Contracts
Luiz Barberini, Head, External Manufacturing Operations, Bayer SA
The pharma industry is facing ever-increasing challenges. Our trials are becoming more complex, requiring greater flexibility, and technology is changing at a fast pace. Now is the time to rethink our outsourcing models. Our dialogue needs to focus on outcomes and value generation rather than arguing over the small things which can stifle innovation. How confident are you with your current approach, and what are the risks and consequences of sticking with the status quo? Our esteemed panel of experts, with diverse backgrounds, will explore how true value can be unlocked from collaborative partners. Key topics include: 1) Creating the right partnership and alliance culture to ensure the best outcome for both the sponsor and vendor; 2) How have procurement functions adapted in defining and measuring value-based contracts?; and 3) Incentivizing and rewarding innovation, and collectively owning a change in strategy.
PANEL DISCUSSION: Unlocking the Crucial Ingredients for a Successful Outsourcing Partnership: Time to Challenge the Status Quo and Focus on Value-Based Contracts
Close of Summit16:25
* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。
