Research map: Identifying regulatory outcomes of Non-interventional Post-Authorisation Safety Studies (PASS) in the European repository of studies using publicly available information

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Papers in this map

  1. Postmarket studies required by the US Food and Drug Administration for new drugs and biologics approved between 2009 and 2012: cross sectional analysis · Joshua David Wallach · 2018 · 77 citations · Cited by this paper
  2. Assessing Research Impact With Bibliometrics and Altmetrics: The Case of the Canadian Network for Observational Drug Effect Studies ( CNODES ) · Alexandra M. Yip · 2026 · Cites this paper
  3. Integrating environmental effects in the benefit-risk assessment of therapeutic products: a proposal and example for sustainable health and healthcare · 2025 · Related
  4. Different Strategies to Execute Multi‐Database Studies for Medicines Surveillance in Real‐World Setting: A Reflection on the European Model · Rosa Gini · 2020 · 70 citations · Cited by this paper
  5. Applications of Pharmacoepidemiology and Pharmacovigilance Studies · Tichawona Chinzowu · 2026 · Cites this paper
  6. Promising treatment biomarkers in asthma · 2023 · Related
  7. Lessons learned on the design and the conduct of Post‐Authorization Safety Studies: review of 3 years of PRAC oversight · Pierre Engel · 2016 · 52 citations · Cited by this paper
  8. Artificial intelligence for optimizing benefits and minimizing risks of pharmacological therapies: challenges and opportunities · 2024 · Related
  9. Proactively managing the risk of marketed drugs: experience with the EMA Pharmacovigilance Risk Assessment Committee · Peter R. Arlett · 2014 · 51 citations · Cited by this paper
  10. Navigating a transforming landscape: the evolving role of pharmacovigilance physicians in drug development and implications for future challenges and training requirements · 2023 · Related
  11. Strengthening standards, transparency, and collaboration to support medicine evaluation: Ten years of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) · Xavier Kurz · 2018 · 48 citations · Cited by this paper
  12. Machine learning analysis of patients’ perceptions towards generic medication in Greece: a survey-based study · 2024 · Related
  13. Large-Scale Postmarketing Surveillance of Biological Drugs for Immune-Mediated Inflammatory Diseases Through an Italian Distributed Multi-Database Healthcare Network: The VALORE Project · Gianluca Trifirò · 2021 · 43 citations · Cited by this paper
  14. Rethinking drug safety signal detection and causality assessment in the age of AI: the risks of incomplete data and biased insights · 2025 · Related
  15. Overview of the European post‐authorisation study register post‐authorization studies performed in Europe from September 2010 to December 2018 · Janet Sultana · 2022 · 20 citations · Cited by this paper
  16. The use of observed-to-expected analyses as a signal detection tool in COVID-19 vaccine safety surveillance: lessons learned from an industry perspective · 2025 · Related
  17. Review of Studies Evaluating Effectiveness of Risk Minimization Measures Assessed by the European Medicines Agency Between 2016 and 2021 · Renske J. Grupstra · 2023 · 20 citations · Cited by this paper
  18. The cutaneous mirror: leveraging drug-induced skin phenotypes as early visual risk signals for systemic toxicity, a comprehensive review · 2026 · Related
  19. The ENCePP Code of Conduct: A best practise for scientific independence and transparency in noninterventional postauthorisation studies · Rosa Gini · 2019 · 17 citations · Cited by this paper
  20. Leveraging real-world data for safety signal detection and risk management in pre- and post-market settings · 2025 · Related
  21. A review of the sampling methodology used in studies evaluating the effectiveness of risk minimisation measures in Europe · Laurence Sophie Jouaville · 2021 · 13 citations · Cited by this paper
  22. Cohort event monitoring of safety of COVID-19 vaccines: the Italian experience of the “ilmiovaccinoCOVID19 collaborating group” · 2024 · Related

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