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Late-phase & PASS study design considerations: Case study

Related topics: Pharmaceutical/Biotech, Europe, Medical Affairs & Stakeholder Engagement, Real-World Evidence & Late-Phase Research, Regulations & Ethics

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Overview
  • When would you choose a retrospective design over a prospective design when planning for a PASS as part of a postmarketing commitment?
  • What have we seen in the PRAC feedback in the past year?
Speaker

Bettina Rillmann
Associate Director, Scientific Affairs
PRA Health Sciences, Germany

REMINDER

This is the presenters’ personal opinion and does not necessarily represent true facts, the official views or policy of their organisation, nor the views of NextLevel Life Sciences.

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