Making real world data real

New methods for EU health technology assessments

Friday, 4 October 2019 | 12:00-13:30 | Kursaal C

Organised by Vital Transformation, supported by Zorginstituut Nederland

With the increasing use of accelerated regulatory tools like the Food and Drug Administration’s breakthrough designation, there are mounting challenges for European health technology assessors (HTAs) to make an accurate assessment of the long-term value and performance of many new therapies. Data presented in evidence is often extrapolated from outcomes measures collected at six months follow-up or less, and what is good enough for regulatory approval often does not meet the requirements for reviewing comparative effectiveness and value in terms of health outcomes for HTAs. This session will introduce a novel, practical approach to harnessing electronic health records and real-world evidence (RWE) to help solve this problem. However, access to robust deidentified patient records in Europe is key.

This session will address the following questions

  • The use of RWE in comparative effectiveness
  • The impact of the GDPR on deidentified patient-level data access
  • HTA needs for new RWE methodologies
  • H2020 programmes that can help fill RWE gaps in the EU

Photo Gallery

Speakers & panellists


  • Anja Schiel, Lead Methodologist in Regulatory and Pharmacoeconomic Statistics, Norwegian Medicines Agency (NoMA)
  • Bettina Ryll, Founder, Melanoma Patient Network Europe
  • Nigel Hughes, Scientific Director, Quantitative Sciences; Co-Lead, IMI EHDEN, Janssen


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