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Evidence generation throughout paediatric medicines life cycle: findings from collaborative work between European Medicines Agency (EMA) and EUnetHTA on use of extrapolation.
Karres D, Pino-Barrio MJ, Benchetrit S, Benda N, Cochat P, Galluzzo S, García-Solís A, Gonzalez S, de Lisa R, Khan D, Lankester R, Lentz F, Martínez-Ortega PA, Montilla S, Morales DR, Tshinanu FM, Sánchez SP, Montero AR, Scherer S, Thomson A, Garrido BT, Umuhire D, Wang S, Bax R, Hedberg N. Karres D, et al. Among authors: hedberg n. Br J Pharmacol. 2024 Nov 22. doi: 10.1111/bph.17396. Online ahead of print. Br J Pharmacol. 2024. PMID: 39574299 Review.
How aligned are the perspectives of EU regulators and HTA bodies? A comparative analysis of regulatory-HTA parallel scientific advice.
Tafuri G, Pagnini M, Moseley J, Massari M, Petavy F, Behring A, Catalan A, Gajraj E, Hedberg N, Obach M, Osipenko L, Russo P, Van De Casteele M, Zebedin EM, Rasi G, Vamvakas S. Tafuri G, et al. Among authors: hedberg n. Br J Clin Pharmacol. 2016 Oct;82(4):965-73. doi: 10.1111/bcp.13023. Epub 2016 Jul 1. Br J Clin Pharmacol. 2016. PMID: 27245362 Free PMC article.
The impact of parallel regulatory-health technology assessment scientific advice on clinical development. Assessing the uptake of regulatory and health technology assessment recommendations.
Tafuri G, Lucas I, Estevão S, Moseley J, d'Andon A, Bruehl H, Gajraj E, Garcia S, Hedberg N, Massari M, Molina A, Obach M, Osipenko L, Petavy F, Petschulies M, Pontes C, Russo P, Schiel A, Van de Casteele M, Zebedin-Brandl EM, Rasi G, Vamvakas S. Tafuri G, et al. Among authors: hedberg n. Br J Clin Pharmacol. 2018 May;84(5):1013-1019. doi: 10.1111/bcp.13524. Epub 2018 Mar 5. Br J Clin Pharmacol. 2018. PMID: 29370449 Free PMC article.
The fourth edition of the European Network for Health Technology Assessment Forum: highlights and outcomes.
Tafuri G, Bélorgey C, Favaretti C, Frénoy E, Giorgio F, Guardian M, Hebborn A, Houÿez F, Imbert J, Lacombe D, Garcia JL, Garrett Z, Petelos E, Saeterdal I, Schuurman A, Skjöldebrand AL, Strammiello V, Widmer D, Willemsen A, Hedberg N. Tafuri G, et al. Among authors: hedberg n. Int J Technol Assess Health Care. 2020 Jun;36(3):191-196. doi: 10.1017/S0266462320000185. Epub 2020 Apr 22. Int J Technol Assess Health Care. 2020. PMID: 32317039
CODE-EHR best practice framework for the use of structured electronic healthcare records in clinical research.
Kotecha D, Asselbergs FW, Achenbach S, Anker SD, Atar D, Baigent C, Banerjee A, Beger B, Brobert G, Casadei B, Ceccarelli C, Cowie MR, Crea F, Cronin M, Denaxas S, Derix A, Fitzsimons D, Fredriksson M, Gale CP, Gkoutos GV, Goettsch W, Hemingway H, Ingvar M, Jonas A, Kazmierski R, Løgstrup S, Thomas Lumbers R, Lüscher TF, McGreavy P, Piña IL, Roessig L, Steinbeisser C, Sundgren M, Tyl B, van Thiel G, van Bochove K, Vardas PE, Villanueva T, Vrana M, Weber W, Weidinger F, Windecker S, Wood A, Grobbee DE; Innovative Medicines Initiative BigData@Heart Consortium, European Society of Cardiology, CODE-EHR international consensus group. Kotecha D, et al. Eur Heart J. 2022 Oct 7;43(37):3578-3588. doi: 10.1093/eurheartj/ehac426. Eur Heart J. 2022. PMID: 36208161 Free PMC article.
Unmet Medical Need: An Introduction to Definitions and Stakeholder Perceptions.
Vreman RA, Heikkinen I, Schuurman A, Sapede C, Garcia JL, Hedberg N, Athanasiou D, Grueger J, Leufkens HGM, Goettsch WG. Vreman RA, et al. Among authors: hedberg n. Value Health. 2019 Nov;22(11):1275-1282. doi: 10.1016/j.jval.2019.07.007. Epub 2019 Sep 6. Value Health. 2019. PMID: 31708064 Free article. Review.
18 results