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Day 1

2nd DECENTRALIZED & HYBRID CLINICAL TRIALS WORLD CONGRESS 2026 EUROPE

Redefining Clinical Research Through Decentralization, Technology, and Collaboration

Millennium Hotel and Conference Centre Gloucester London, UK

Day 1 - Wednesday 25th February 2026

Amelia Hursey, Strategic Director, parkinsonseurope.org

Regulation, Collaboration, and Patient Engagement

  • Key updates on the CTR and its practical implications for DCT operations
  • Coordinating approvals via the Clinical Trials Information System (CTIS)
  • Managing ethics submissions and multi-country compliance challenges
  • Building trust and transparency through harmonized EU oversight

Moderator:

Alexandra Charge, Chief Executive Officer, ISPEP

Panelist:

Khadija Rantell, Senior Statistical Assessor, MHRA

Elizabeth Theogaraj, Regulatory Senior Group Director, Roche

  • MHRA patient involvement strategy
  • Current landscape and regulatory considerations

Khadija Rantell, Senior Statistical Assessor, MHRA

  • Decentralised elements in Clinical trials
  • Industry’s perspectives in adopting DCT elements in Clinical Trials
  • How European regulators are enabling DCT adoption
  • EFPIA Recommendation Paper on Advancing the Use of Decentralised Elements in Clinical Trials

Elizabeth Theogaraj, Regulatory Senior Group Director, Roche

  • Reducing barriers to participation for rural and aging populations
  • Strategies for multi-language patient interfaces and digital inclusion
  • Leveraging telehealth to improve representation in rare disease studies
  • Building national digital literacy programs for broader engagement

Prof Gary Middleton, Clinical Network Lead, ECMC

  • Advances in validated wearables, eConsent, and ePRO platforms
  • Interoperability with hospital EHR systems
  • Ensuring MDR/IVDR compliance for medical device-linked technologies
  • Real-world deployment case studies from multicountry trials
  • Governance, regulatory and clinical frameworks
  • Ethical perspectives
  • Operational feasibility

Emma Kinloch, CEO, Salivary Gland Cancer UK

  • Bullet points to follow

Lewis Millen, Head of Clinical Innovation & Digital Solutions, UCB

  • A five letter code: what a diagnosis unlocks
  • Building momentum: patients, science, collaboration
  • From repurposing to personalised medicine: progress, promise, and barriers in ultra-rare treatment development
  • Why speed matters: the cost of waiting

Melanie Dixon, Trustee, Cure DHDDS

  • Blending virtual and in-person interactions to enhance experience
  • Supporting patients through multilingual, digital, and in-clinic channels
  • Ensuring safety, adherence, and satisfaction in hybrid environments
  • The path toward a unified, inclusive European patient-centric model

Nadya Isack, Patient and Public Involvement (PPIE) Advocate, Founder, Empower Health Initiative CIC, Person living with Obesity

  • This talk will explore how patient insights can guide the design and implementation of decentralized and hybrid clinical trials from early development stages.
  • By incorporating the patient perspective, sponsors can adapt endpoints, visit schedules, and participation burden to better reflect real-world needs, improving recruitment, retention, and overall patient satisfaction.
  • Practical examples will be shared demonstrating how decentralized approaches — including digital tools, telemonitoring, ePROs, and wearable devices — can be leveraged to enhance efficiency, accessibility, and engagement.

Laura Risueño Ayerbe, Global Patient Affairs, Patient Engagement R&D, Servier

  • Fostering pan-European ecosystems for DCT service delivery
  • Integrating SMEs and digital health star tups into large-scale trials
  • Coordinating cross-border logistics, training, and support networks
  • Establishing standardized performance and quality metrics

Moderator:

Dr Sondra Butterworth, Community Psychologist, CEO, RareQoL

Panelist:

Fiona Adshead, Chair, Sustainable Healthcare Coalition

Dimitris Christodoulou, Digital Health Business Lead, Roche

Amelia Hursey, Strategic Director, parkinsonseurope.org 

Joint Networking & Exhibit Area. 

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