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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
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