Regulatory Science at the Lygature Partnerships MeetUp – 1 November

01 November 2018
Utrecht, The Netherlands
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On November 1st, Lygature organizes their third annual Partnerships MeetUp in Utrecht, with an inspiring keynote speech by Tomas Salmonson – the current chair of the Committee for Medicinal Products for Human Use, CHMP, European Medicines Agency, EMA. During the morning parallel session of the Lygature Partnerships MeetUp, an interesting session on ‘Extrapolation in Regulatory Science’ will be organized with speakers Prof. Dr. Kit Roes (Julius Center, Utrecht), Dr. Wim Goettsch (Zorginstituut Nederland), Prof. Dr. Saskia de Wildt (Radboud UMC) and Prof. Dr. Bert Leufkens (UU/Lygature) as moderator of the session.

In the coming decades, so-called precision treatments aimed at relatively small and well-defined patient populations will impact current methods of data collection. This will, on the one hand, increase the need for extrapolation to different patient populations, clinical settings or development stages and, on the other hand, allow for more refined extrapolation methods that exploit available data more effectively. These new extrapolation methods may play an important role in approaches for regulatory assessments, Health Technology Assessments (HTA) and clinical use.

In the ‘Extrapolation in Regulatory Science’ morning parallel session (10:00-12:00) we will explore the perspectives and experiences from different stakeholders on how extrapolation in clinical drug development, regulation, HTA and clinical practice is currently applied, and which challenges we may face with regard to acceptance of novel methods for extrapolation.

For more information and registration, visit the website.