Building HTA insights into the drug development plan: Current approaches to seeking early scientific advice from HTA agencies

Autor: Wang, Ting, McAuslane, Neil, Gardarsdottir, Helga, Goettsch, Wim G, Leufkens, Hubert G M, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology

Publikováno v: Drug Discovery Today, 27(1), 347. Elsevier Ltd

There is a growing trend for pharmaceutical companies to seek scientific advice on drug development from a Health Technology Assessment (HTA) perspective, to improve the efficiency of their studies, enable better trial design, and support the goals o

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::abbacb6aee2700991fbd5ae2f02ac9d9
https://dspace.library.uu.nl/handle/1874/416184

How aligned are the perspectives of EU regulators and HTA bodies? A comparative analysis of regulatory-HTA parallel scientific advice

Autor: Jane Moseley, Antje Behring, Frank Pétavy, Mercè Obach, Niklas Hedberg, Guido Rasi, Leeza Osipenko, Arantxa Catalan, Eva‐Maria Zebedin, Pierluigi Russo, Marco Massari, Marc Van de Casteele, Spiros Vamvakas, Elangovan Gajraj, Margherita Pagnini, Giovanni Tafuri

Publikováno v: British Journal of Clinical Pharmacology

BACKGROUND: In 2010, the European Medicines Agency (EMA) initiated a pilot project on parallel scientific advice with Health Technology Assessment bodies (HTABs) that allows manufacturers to receive simultaneous feedback from both the European Union

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::36cf2a1c2295f7f9c367a9b9de384308
https://lirias.kuleuven.be/handle/123456789/669469

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Building HTA insights into the drug development plan: Current approaches to seeking early scientific advice from HTA agencies.

Autor: Wang T; Centre for Innovation in Regulatory Science (CIRS), London, UK; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands. Electronic address: twang@cirsci.org., McAuslane N; Centre for Innovation in Regulatory Science (CIRS), London, UK., Gardarsdottir H; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands., Goettsch WG; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands; National Health Care Institute, Diemen, the Netherlands., Leufkens HGM; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands.

Publikováno v: Drug discovery today [Drug Discov Today] 2022 Jan; Vol. 27 (1), pp. 347-353. Date of Electronic Publication: 2021 Sep 28.