7 - 9 November 2022
Live In-Person Event: 7 - 9 November, RAI, Amsterdamkeyboard_arrow_right
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DAY TWO - CET/CEST (Cent Europe Summer, GMT+2)
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DAY TWO - CET/CEST (Cent Europe Summer, GMT+2)
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08:50 - 09:0010 mins
Partnerships, Outsourcing, Regulation & RWE
Chairperson Opening Comments
08:50 - 09:0010 mins
Operations: Patient Engagement, Recruitment and Diversity
Chairperson Opening Comments
08:50 - 09:0010 mins
Operations: Post Pandemic, Military Conflict, Novel Design and Sustainability
Chairperson Opening Comments
08:50 - 09:0010 mins
Decentralized Clinical Trials
Chairperson Opening Comments
08:50 - 09:0010 mins
Digital Health
Chairperson Opening Comments
09:00 - 09:3030 mins
Partnerships, Outsourcing, Regulation & RWE
Compromise and Meet in the Middle: What Makes a Partnership Work?
09:00 - 09:3030 mins
Operations: Patient Engagement, Recruitment and Diversity
A Platform to Improving Access to Clinical Trials
- Brian Goodman - Program Manager, Synergist & Patient Focused Medicines Development, Switzerland
09:00 - 09:3030 mins
Operations: Post Pandemic, Military Conflict, Novel Design and Sustainability
Execution of a Clinical Trial with a Rare Disease During a Pandemic
- Christopher Missling - President & CEO, Anavex Life Sciences, USA
09:00 - 09:3030 mins
Decentralized Clinical Trials
Advancing DCTs: Updated CTTI Recommendations Reflect Experience to Date
- Lewis Millen - Innovation Lead, Global Clinical Sciences & Operations, UCB, UK
09:00 - 09:3030 mins
Digital Health
Innovation – Understanding the Timeline for Adoption of Technologies in Clinical Research
- Kenneth Getz - Director & Research Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine, USA
09:30 - 10:0030 mins
Partnerships, Outsourcing, Regulation & RWE
How Collaboration Between Technology and Operations Vendors Enable Faster and More Patient-Centric
- Mike Hutton - Head of Strategic Partnerships and Alliances, Almac Clinical Technologies, USA
- Amaury Jeandrain - Head of Business Development Engineering, Life Sciences, N-SIDE, USA
09:30 - 10:0030 mins
Operations: Patient Engagement, Recruitment and Diversity
Spotlight Presentation: IQVIA
09:30 - 10:0030 mins
Operations: Post Pandemic, Military Conflict, Novel Design and Sustainability
Modernizing Clinical Trial Conduct: Fit-for-Purpose Trials of the Future
- Maurits Kok - Clinical Program Director, UCB, Germany
09:30 - 10:0030 mins
Decentralized Clinical Trials
Spotlight Presentation
09:30 - 10:0030 mins
Digital Health
Digital Strategy for Globalisation of Clinical Trials
- Adama Ibrahim - Digital Solutions Director, Novartis, Switzerland
10:00 - 10:3030 mins
Partnerships, Outsourcing, Regulation & RWE
How Multiple CROS work together on a Sponsor Project?
10:00 - 10:3030 mins
Operations: Patient Engagement, Recruitment and Diversity
Patient Equity and Partnership: From After-Action to Co-Creation TransCelerate Initiative: Diversity of Participants in Clinical Trials and Patient Experience
- William Dott - Patient Insights and Solutions Lead, AstraZeneca, UK
10:00 - 10:3030 mins
Operations: Post Pandemic, Military Conflict, Novel Design and Sustainability
The Impact of AI/ML Innovation Across the Clinical Trial Lifecycle
- Wendy Morahan - Senior Director, Clinical Data Analytics, IQVIA Technologies, USA
10:00 - 10:3030 mins
Decentralized Clinical Trials
Practical Experiences of Future Proofing Clinical Trials using the Decentralized Approach
- Wendi Lau - Senior Director, Clinical Development Operations, Abbvie, USA
10:00 - 10:3030 mins
Digital Health
Spotlight Presentation
10:30 - 11:1040 mins
Morning Coffee
11:10 - 11:4030 mins
Partnerships, Outsourcing, Regulation & RWE
Spotlight Presentation
11:10 - 11:4030 mins
Operations: Patient Engagement, Recruitment and Diversity
Decentralized Clinical Trials in Paediatrics
- Joana Claverol - Clinical Research Unit Manager, Barcelona Children’s Hospital Sant Joan de Déu, Spain
11:10 - 11:4030 mins
Operations: Post Pandemic, Military Conflict, Novel Design and Sustainability
Clinician Perspective: Potential Lessons Learnt during the Pandemic
- Christopher Twelves - Professor of Medical Oncology, St James’s Institute of Oncology, UK
11:10 - 11:4030 mins
Decentralized Clinical Trials
Covid- DCT Trials: Incorporating Telemedicine into Clinical Trials
- Esther Howard - Oncology Advisor, THREAD Research, USA
11:10 - 11:4030 mins
Digital Health
Use and Benefits of Web-Based Patient Portals in Daily Oncology Routine
- Bernhard Holzner - Evaluation Software Development, Medical University of Innsbruck, Austria
11:40 - 12:1030 mins
Partnerships, Outsourcing, Regulation & RWE
Regulatory Best Practices of the Clinical Trial Regulation and the Accelerated Clinical Trials in EU, HMA, EMA and EU Commission Initiative
- Gunilla Andrew-Nielsen - Head of Department of Clinical Trials and Special Permissions, Swedish Medical Projects Agency, Sweden
11:40 - 11:5515 mins
Operations: Patient Engagement, Recruitment and Diversity
Spotlight Presentation: Clinical Trial Feasibility in a Changing World
- Olawale Salami - Head of Project Management and Feasibility, SGS Health Science, Belgium
11:40 - 12:1030 mins
Operations: Post Pandemic, Military Conflict, Novel Design and Sustainability
Revisioning Clinical Trials for the Future
- Francis P. Crawley - Coordinator, European Fellowship in Research Ethics (EFRE), Executive Director, Good Clinical Practice Alliance - Europe (GCPA), Belgium
11:40 - 12:1030 mins
Decentralized Clinical Trials
Learnings from a Fully Decentralized Trial in Oncology and a Hybrid Decentralized in Autism
- Lisa Shafe - Clinical Programme Leader, Roche, UK
- Thomas Wiese - Principal Medical Director, Clinical Expert Team Leader, Roche Pharma Research & Early Development, F.Hoffmann-La Roche Ltd, Switzerland
11:40 - 12:1030 mins
Digital Health
Spotlight Presentation
11:55 - 12:2530 mins
Operations: Patient Engagement, Recruitment and Diversity
The Future of Clinical Trials in the UK Post-Brexit - a Patient and Participant Perspective
- Richard Stephens - Chair of the National Cancer Research Institute's Consumer Forum, National Cancer Research Institute’s Consumer Forum (NCRI), UK
12:10 - 12:4030 mins
Partnerships, Outsourcing, Regulation & RWE
Impact and Industry Perspective for EU Clinical Trial Regulation 536/2014
- Shaila Choi - Director Regulatory Affairs, Seagen, UK
12:10 - 12:4030 mins
Operations: Post Pandemic, Military Conflict, Novel Design and Sustainability
Spotlight Presentation: Greenphire
12:10 - 12:4030 mins
Decentralized Clinical Trials
Innovation – Understanding the Timeline for Adoption of Technologies in Clinical Research
- Kenneth Getz - Director & Research Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine, USA
12:10 - 12:4030 mins
Digital Health
Validation of Digital Health using Digital End Points
- Lada Leyens - Global Regulatory lead - Clinical Trial Innovation and Digital Health, Roche, Switzerland
12:25 - 12:4015 mins
Operations: Patient Engagement, Recruitment and Diversity
Spotlight Presentation:
12:40 - 14:0080 mins
Lunch
14:00 - 14:3030 mins
Partnerships, Outsourcing, Regulation & RWE
Spotlight Presentation
14:00 - 14:3030 mins
Operations: Patient Engagement, Recruitment and Diversity
Collaborative Work with Different Hospitals with the Network - Patients’ Advisory Groups
- Begonya Nafria Escalera - Patient Engagement in Research Coordinator, Barcelona Children's Hospital Sant Joan de Deu, Spain
14:00 - 14:3030 mins
Operations: Post Pandemic, Military Conflict, Novel Design and Sustainability
Spotlight Presentation
14:00 - 14:3030 mins
Decentralized Clinical Trials
Trials@Home Findings Including the Initial Radial Study Learnings
- Mira Zuidgeest - Assistant Professor, University Medical Center Utrecht, The Netherlands
14:00 - 14:3030 mins
Digital Health
Spotlight Presentation
14:30 - 15:0030 mins
Partnerships, Outsourcing, Regulation & RWE
Transparency of Database and the Classification of Trials
- Peter Bogaert - Partner, Covington & Burling LLP, Brussels
14:30 - 15:0030 mins
Operations: Patient Engagement, Recruitment and Diversity
Spotlight Presentation: Medable
14:30 - 15:0030 mins
Operations: Post Pandemic, Military Conflict, Novel Design and Sustainability
How to Conduct Clinical Trials Under a Military Threat
- Roman Fishchuk - CEO, Clinical Trials Unit, Central City Clinical Hospital of Ivano-Frankivsk City Council, Ukraine
14:30 - 15:0030 mins
Decentralized Clinical Trials
Spotlight Presentation
14:30 - 15:0030 mins
Digital Health
Transforming the Document Paradigm to Digitize Clinical Study Start Up: TransCelerate’s Digital Data Flow Initiative TransCelerate Initiative: Digital Data Flow
15:00 - 15:4040 mins
Partnerships, Outsourcing, Regulation & RWE
PANEL: What Does Long Term Partnerships Really Mean?
- Anna Matranga - Managing Director, AMC Alliances & Consulting, France
- Sigrid Viergutz - Global Clinical Trial Operations (GCTO), MSD Sharp & Dohme GmbH, A. Germany
- Paul Bouten - Owner, PharmCMed, The Netherlands
15:00 - 15:4040 mins
Operations: Patient Engagement, Recruitment and Diversity
PANEL: Develop Long-Lasting Relationships that Strengthen Patient Involvement and Embeds them into Business Decision Making
- Isabelle Naeije - Associate Global Trial Director, Novartis, Switzerland
- Begonya Nafria Escalera - Patient Engagement in Research Coordinator, Barcelona Children's Hospital Sant Joan de Deu, Spain
- Ben Cromarty - York and Scarborough Teaching Hospital Peer Mentor, UK-CAB, Medical Research Council Clinical Trials Unit at University College London Patient and Public Involvement Group, UK
15:00 - 15:4040 mins
Operations: Post Pandemic, Military Conflict, Novel Design and Sustainability
PANEL: Learnings from the Recent Pandemic- How to manage a Pandemic in the Future
- Shaila Choi - Director Regulatory Affairs, Seagen, UK
- Edward Walsh - Senior Director, Regional Clinical Trial Operations Europe, Seagen International GmbH, Switzerland
15:00 - 15:4040 mins
Decentralized Clinical Trials
PANEL: Biggest Learning- One Size for DCT Doesn’t Fit All
15:00 - 15:3030 mins
Digital Health
EConsent – What is the Patient informed Consent Process?
- Nael Abdelsamad - Program Director, HEAL Pain Management Effectiveness Research Network, University of Utah, USA
15:40 - 16:2040 mins
Afternoon Coffee
16:20 - 16:5030 mins
Partnerships, Outsourcing, Regulation & RWE
Spotlight Presentation
16:20 - 16:5030 mins
Operations: Patient Engagement, Recruitment and Diversity
Case Study of Dynamic Patient Involvement in Precision Medicine
- Stephen Nabarro - Head of Clinical Operations and Data Management, Cancer Research UK Centre for Drug Development, UK
16:20 - 16:5030 mins
Operations: Post Pandemic, Military Conflict, Novel Design and Sustainability
TO FILL
16:20 - 16:5030 mins
Decentralized Clinical Trials
Spotlight Presentation: Clario
16:20 - 16:5030 mins
Digital Health
Spotlight Presentation
16:50 - 17:2030 mins
Partnerships, Outsourcing, Regulation & RWE
Interpretation of the latest ICH Regulatory Updates
- Kristof Van Quathem - Special Counsel, Covington & Burling LLP, Brussels
16:50 - 17:2030 mins
Operations: Patient Engagement, Recruitment and Diversity
Spotlight Presentation
16:50 - 17:2030 mins
Operations: Post Pandemic, Military Conflict, Novel Design and Sustainability
Efficiency of Clinical Trials using Adaptive Design and Implementing Value of Hope into Medical and Regulatory Decision Making
- Jorg Mahlich - Head of Health Economics & Outcomes Research, Miltenyi Biomedicine- Janssen - leaving, Germany
16:50 - 17:2030 mins
Decentralized Clinical Trials
Regularity Viewpoint from the MHRA on Decentralized Clinical Trials
- Khadija Rantell - Statistical Assessor, Medicines and Health Care Products Regulatory Agency (MHRA), UK
16:50 - 17:2030 mins
Digital Health
Digital Measurement Standards: What are They and How can They Enable the Scalable use of Digitally Derived Evidence?
- Kai Langel - Senior Director, Strategy and Innovation, Global Regulatory Policy and Intelligence, Janssen R&D, Belgium
- Bert Hartog - Senior Director, Janssen Clinical Innovation, Janssen R&D Global Development, The Netherlands
17:20 - 17:5030 mins
Partnerships, Outsourcing, Regulation & RWE
Real World Data in Practice- Perspectives from a Regulator and a Clinician
- Tim Williams - Research Team Manager, Medicines and Health Care Products Regulatory Agency (MHRA), UK
17:20 - 17:5030 mins
Operations: Patient Engagement, Recruitment and Diversity
How Seagen Continued with Clinical Research During the Pandemic
- Edward Walsh - Senior Director, Regional Clinical Trial Operations Europe, Seagen International GmbH, Switzerland
17:20 - 17:5030 mins
Operations: Post Pandemic, Military Conflict, Novel Design and Sustainability
Spotlight Presentation
17:20 - 17:5030 mins
Decentralized Clinical Trials
Industry Talk
17:20 - 17:5030 mins
Digital Health
Streamlining Clinical Research Process by Using AI as the Driver
- Tina Barton - Chief Operating Officer, eMQT, UK
17:50 - 19:30100 mins
Partnerships, Outsourcing, Regulation & RWE
CTE Drinks Reception
17:50 - 19:30100 mins
Operations: Patient Engagement, Recruitment and Diversity
CTE Drinks Reception
17:50 - 19:30100 mins
Operations: Post Pandemic, Military Conflict, Novel Design and Sustainability
CTE Drinks Reception
17:50 - 19:30100 mins
Decentralized Clinical Trials
CTE Drinks Party
17:50 - 19:30100 mins
Digital Health
CTE Drinks Party
19:30 - 19:355 mins
Partnerships, Outsourcing, Regulation & RWE
End of Day Two
19:30 - 19:355 mins
Operations: Patient Engagement, Recruitment and Diversity
End of Day Two
19:30 - 19:355 mins
Operations: Post Pandemic, Military Conflict, Novel Design and Sustainability
End of Day Two
19:30 - 19:355 mins
Decentralized Clinical Trials
End of Day Two
19:30 - 19:355 mins
Digital Health
End of Day Two
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