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Overview

The Future of Clinical Trials is Decentralised.

During the pandemic, decentralised clinical trials became more and more relevant. With moving away from on-site trials, this new trend changes the reality of big and complex data management, the use of artificial intelligence tools and new regulatory frameworks. How do we manage gathering, storage and processing of data in a decentralised environment? The community still discusses the full application of CTIS and the regulatory application.

At the Clinical Trials and Data Science Conference, decision-makers across the industry, regulatory and patient organisations will meet to discuss the future of clinical trials to find innovative solutions.

Key Topics

  • Decentralised Clinical Trials
  • Use of Data Science in Clinical Trials
  • Updates on the EMA/HMA Big Data Taskforce
  • DARWIN EU
  • Data Protection and Security
  • Artificial Intelligence Regulatory Frameworks: Impact on Pharma
  • IMI Initiatives
  • European Health Data Space (EHDS)
  • RWE

Program Committee

  • Álmath Máire Spooner, PhD, RPh
    Álmath Máire Spooner, PhD, RPh Director of Regulatory Policy and Intelligence
    AbbVie, Ireland
  • Daniel  Millar, MBA
    Daniel Millar, MBA Senior Director, Strategic Business Transformation Quantitative Sciences
    Janssen Research & Development, United States
  • Elke  Stahl, PhD
    Elke Stahl, PhD Senior Expert, Clinical Trials Department
    Federal Institute For Drugs and Medical Devices (BfArM), Germany
  • Jesper  Kjær, MS
    Jesper Kjær, MS Co-Chair, EMA/HMA Big Data Steering Group; Director of Data Analytics Centre
    Danish Medicines Agency (DKMA), Denmark
  • Patrick  Brady, PharmD
    Patrick Brady, PharmD Head Regulatory Policy & Intelligence
    Bayer AG / Research & Development, Pharmaceuticals, Germany
  • Nick  Sykes, MS
    Nick Sykes, MS Senior Director, Global Regulatory Affairs
    Pfizer Inc, United Kingdom
  • Ruediger  Pankow, DrSc
    Ruediger Pankow, DrSc Principal Consultant, Regulatory Affairs
    Parexel International, Germany
  • Fia  Westerholm, DVM, MSc
    Fia Westerholm, DVM, MSc Programme Assurance Manager
    European Medicines Agency, Netherlands
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