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Optimizing Patient Registries for Regulatory Decision Making - Key Learnings From an HMA/EMA Multistakeholder Workshop.
Plueschke K, Jonker C, Kankanen H, Vetter T, Sepodes B, Naehrlich L, Hillert J, Crane G, Straus S, Foggi P, Martin S, Kyriakopoulou C, Mol P, Day F, Breen K, Bennett N, de Lemus Belmonte M, Bennett S, Verpillat P, Roes KCB, Cochino A, Schaefer F, Hernández-Rivas JM, McGettigan P, Arlett P. Plueschke K, et al. Among authors: jonker c. Clin Pharmacol Ther. 2025 Jun 2. doi: 10.1002/cpt.3733. Online ahead of print. Clin Pharmacol Ther. 2025. PMID: 40457718 Review.
Registries supporting new drug applications.
Jonker CJ, van den Berg HM, Kwa MSG, Hoes AW, Mol PGM. Jonker CJ, et al. Pharmacoepidemiol Drug Saf. 2017 Dec;26(12):1451-1457. doi: 10.1002/pds.4332. Epub 2017 Oct 6. Pharmacoepidemiol Drug Saf. 2017. PMID: 28983992 Free PMC article.
Framework for Multistakeholder Patient Registries in the Field of Rare Diseases: Focus on Neurogenetic Diseases.
Schoenmakers DH, van den Berg S, Timmers L, Adang LA, Bäumer T, Bosch A, van de Casteele M, Datema MR, Dekker H, Donnelly C, Driessens MHE, Graessner H, Greger V, Haddad T, Höglinger GU, van den Hout H, Jonker C, Langeveld M, Lambert LJ, Neacy E, Nieuwland M, Klockgether T, van der Knaap MS, Papadopoulou A, Plueschke K, van Rijn S, Rosenberg N, Saunier-Vivar EF, Dos Santos Vieira B, Hollak CEM, Goettsch WG, Wolf NI. Schoenmakers DH, et al. Among authors: jonker c. Neurology. 2024 Sep 24;103(6):e209743. doi: 10.1212/WNL.0000000000209743. Epub 2024 Aug 22. Neurology. 2024. PMID: 39173102 Free PMC article.
Real world evidence: Perspectives from a European Society of Cardiology Cardiovascular Round Table with contribution from the European Medicines Agency.
Szymański P, Weidinger F, Lordereau-Richard I, Himmelmann A, Arca M, Chaves J, Lee C, Jonker C, Kotecha D, O'Kelly J, Plueschke K, Ryś A, Segec A, Wallentin L, Veltrop R, James S. Szymański P, et al. Among authors: jonker c. Eur Heart J Qual Care Clin Outcomes. 2023 Feb 28;9(2):109-118. doi: 10.1093/ehjqcco/qcad009. Eur Heart J Qual Care Clin Outcomes. 2023. PMID: 36746430
214 results