Implementation of EU risk minimisation measures for medicinal products in clinical guidelines
For more information on this project, please contact the EU PE&PV research network at eupepv@uu.nl.
Project information
- EU PE&PV research network
- EUPAS47588
- Specific Contract 01 implementing Framework service contract EMA/2020/46/TDA/L4.02
Full title
Implementation of EU risk minimisation measures for medicinal products in clinical guidelines
Principal investigator
Prof. Dr. Helga Gardarsdottir, Utrecht University
Participating organisations
- Utrecht University, The Netherlands - co-lead, consortium lead
- University of Copenhagen, Denmark - co-lead
- Democritus University of Thrace, Greece
- Rīga Stradiņš University, Latvia
- RIVM, The Netherlands
- UMC Utrecht, The Netherlands
- University of Porto, Portugal
- University of Ljubljana, Slovenia
Status
Completed (2023)
Deliverables
Peer-reviewed scientific publications
- Medicines safety information from regulators in clinical practice guidelines: a mixed-method case study. Armin Andersen, Mathias Møllebæk, Anna Birna Almarsdóttir. Journal of Pharmaceutical Health Services Research, Volume 16, Issue 1, March 2025, rmae023, https://doi.org/10.1093/jphsr/rmae023
- Challenges in the Implementation of EU Risk Minimisation Measures for Medicinal Products in Clinical Practice Guidelines: Mixed Methods Multi-Case Study. Møllebæk M, Gardarsdottir H, Bikou AG, Kodrič A, Silva AM, Andersen A, Kontogiorgis C, Poplavska E, Ahmadizar F, Dermiki-Gkana F, Rutkovska I, Vaz IR, Kos M, Barão P, Grupstra R, Alves TL, Almarsdóttir AB. Drug Saf. 2025 Feb;48(2):161-177. doi: 10.1007/s40264-024-01487-5. Epub 2024 Nov 21. PMID: 39570566; PMCID: PMC11785605.
- Risicominimalisatiemaatregelen voor geneesmiddelen [Risk minimalisation measures for medications; are they incorporated in Dutch clinical guidelines?]. Grupstra RJ, Siiskonen SJ, Gardarsdottir H. Ned Tijdschr Geneeskd. 2024 Jun 25;168:D8139. Dutch. PMID: 38888389.