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Clinical Trials Europe
Mark Your Calendar for 2023!
31 October - 2 November 2023Koelncongress Convention Centre
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DAY THREE - CET/CEST (Cent Europe Summer, GMT+2)

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DAY THREE - CET/CEST (Cent Europe Summer, GMT+2)

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08:20 - 08:5030 mins
Partnerships, Outsourcing, Regulation & RWE
Morning Coffee
    08:20 - 08:5030 mins
    Operations
    Morning Coffee
      08:20 - 08:5030 mins
      Decentralized Clinical Trials
      Morning Coffee
        08:50 - 09:0010 mins
        Partnerships, Outsourcing, Regulation & RWE
        Chairperson Opening Comments
        • Rebecca Jackson - Senior Manager, Clinical Development and Innovation BTL, Janssen, UK
        08:50 - 09:0010 mins
        Operations
        Chairperson Opening Comments
        • Lisa Shafe - Clinical Programme Leader, Roche, UK
        08:50 - 09:0010 mins
        Decentralized Clinical Trials
        Chairperson Opening Comments
        • Tina Barton - Chief Operating Officer, eMQT, UK
        09:00 - 09:3030 mins
        Partnerships, Outsourcing, Regulation & RWE
        The Evaluation and Selection of Real World Data Sources – A Buyers Perspective
        • Robert Byrne - Senior Global Category Manager, RWE, Novartis, Ireland
        09:00 - 09:3030 mins
        Operations
        Clinical Development in a Post Pandemic World
        • Raj Modi - Senior Director, Health Sciences, Oracle, UK
        09:00 - 09:3030 mins
        Decentralized Clinical Trials
        Making Every Data Point Count: The Value of Machine-Readable, FAIR (Meta)data in Clinical Research
        • Martijn Kersloot - Product Owner, Assistant Professor in Medical Informatics, Castor, Amsterdam University Medical Centers, The Netherlands
        09:30 - 10:0030 mins
        Partnerships, Outsourcing, Regulation & RWE
        The Pivot to RWD Studies: Operational Insights From Leveraging Longitudinal RWD Data in a Rare-disease Study
        • Shruti MP - Data Solutions Architect, Associate Program Director, Parexel International, India
        09:30 - 10:0030 mins
        Operations
        Leveraging Behavioural Science in Understanding and Engaging Patient Preference: Voice of the Patient – More Than a Mere “tick-box” Exercise?
        • Melissa Harris - Director, Global Patient Engagement, Labcorp, UK
        09:30 - 10:0030 mins
        Decentralized Clinical Trials
        Closing the Cure Acceleration Gap with Site Enablement
        • Blake Adams - SVP, Marketing and Growth, Florence Healthcare, USA
        10:00 - 10:4040 mins
        Partnerships, Outsourcing, Regulation & RWE
        PANEL: Real World Evidence – Experiences
        • Michael Zörer - Head of Clinical Operations, VarmX , The Netherlands
        • Christopher Twelves - Professor of Medical Oncology, St James’s Institute of Oncology, UK
        • Tim Williams - Research Team Manager, Medicines and Health Care Products Regulatory Agency (MHRA), UK
        • Maria Florez - Research Consultant, Tufts Center for the Study of Drug Development, Tufts University School of Medicine, USA
        10:00 - 10:4040 mins
        Operations
        PANEL: Addressing the Emerging Challenge of Digital Health Care Waste
        • Jason LaRoche - Director, Focus Area Lead, Janssen Clinical Innovation, Janssen R&D, USA
        • Els Ducheyne - Senior Manager Material Compliance, Johnson & Johnson, Belgium
        • Jeremy Faludi - Assistant Professor, Industrial Design Engineering, TU Delft, The Netherlands
        • Alfred Jager - Commercial Director, MIREC, The Netherlands
        • Harald Tepper - Program Lead Circular Economy and EcoDesign, Philips, The Netherlands
        10:00 - 10:3030 mins
        Decentralized Clinical Trials
        Wait! What About the Patient?
        • Caroline Potts - VP - Visit Delivery, MRN, UK
        10:40 - 11:1030 mins
        Morning Coffee
          11:10 - 11:4030 mins
          Partnerships, Outsourcing, Regulation & RWE
          Practical Tools Available to Advance Fit-for-Purpose Use of Real World Data (RWD) in Regulatory Decision-Making
          • Claudia Cabrera-Moksnes - Sr Director Epidemiology and Evidence Excellence; Real World Science & Analytics, BioPharmaceutical Medical at AstraZeneca, Sweden, AstraZeneca, Sweden
          11:10 - 11:4030 mins
          Operations
          FIRESIDE CHAT: Transitioning Clinical Research Towards Sustainability
          • Bert Hartog - Senior Director, Focus Area Lead, Janssen Clinical Innovation, Janssen R&D, The Netherlands
          • Jason LaRoche - Director, Focus Area Lead, Janssen Clinical Innovation, Janssen R&D, USA
          11:10 - 11:4030 mins
          Decentralized Clinical Trials
          Decentralized Clinical Trials in Paediatrics
          • Joana Claverol - Clinical Research Unit Manager, Barcelona Children’s Hospital Sant Joan de Déu, Spain
          11:40 - 12:1030 mins
          Partnerships, Outsourcing, Regulation & RWE
          Real World Data - Use of HR Data in Covid Research and Beyond
          • Rebecca Jackson - Senior Manager, Clinical Development and Innovation BTL, Janssen, UK
          11:40 - 12:1030 mins
          Operations
          Investigative Site Staff Diversity: A Global Assessment and Implications for Patient Enrollment and Retention in Clinical Trials
          • Maria Florez - Research Consultant, Tufts Center for the Study of Drug Development, Tufts University School of Medicine, USA
          11:40 - 12:1030 mins
          Decentralized Clinical Trials
          Regularity Viewpoint from the MHRA on Decentralized Clinical Trials
          • Khadija Rantell - Senior Statistical Assessor, Medicines and Health Care Products Regulatory Agency (MHRA), UK
          12:10 - 12:4030 mins
          Partnerships, Outsourcing, Regulation & RWE
          JOINT PRESENTATION: Enabling Trials Using Real World Data: Implementing a Clinical Trial Within Routine Community Healthcare
          • Tim Williams - Research Team Manager, Medicines and Health Care Products Regulatory Agency (MHRA), UK
          • Dipak Kotecha - Professor of Cardiology & Cardiac Imaging and Consultant Cardiologist, University of Birmingham & University Hospitals Birmingham NHS Foundation Trust, UK
          12:10 - 12:4030 mins
          Operations
          PANEL: The Netherlands Accelerating Clinical Research
          • Benien Vingerhoed - Co-Director, FAST (Centre for Future Affordable and Sustainable Therapy Development), The Netherlands
          • Stan van Belkum - Director, The Central Committee on Research Involving Human Subjects (CCMO), The Netherlands
          • Remco Roobol - Group Head Clinical Operations, Novartis, The Netherlands
          • Astrid Schut - Managing Director, Dutch Network for Cardiovascular Research (WCN), The Netherlands
          12:10 - 12:4030 mins
          Decentralized Clinical Trials
          Decentralized Trials: EU Level Regulation vs Local Regulation
          • Elizabeth Theogaraj - Global Regulatory Lead, Roche, Switzerland
          12:40 - 12:455 mins
          End of Conference
            DAY TWO
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