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Akademický článek

Risk Management Plans: reassessment of safety concerns based on Good Pharmacovigilance Practices Module V (Revision 2)—a company experience

Autor: Suzan Esslinger, Linda Quinn, Sami Sampat, Marijo Otero-Lobato, Wim Noël, Anja Geldhof, Nicole Herijgers, Sarah-Jane Reeder

Publikováno v: Journal of Pharmaceutical Health Care and Sciences, Vol 8, Iss 1, Pp 1-15 (2022)

Abstract Introduction In the European Union (EU), a Risk Management Plan (RMP) is submitted as part of the dossier for initial marketing authorization of a medicinal product or with an application involving a significant change to an existing marketi

Externí odkaz: https://doaj.org/article/1dfec1e1580b49d5ab6ef74bb17fea62

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Risk Management Plans: reassessment of safety concerns based on Good Pharmacovigilance Practices Module V (Revision 2)-a company experience

Autor: Suzan Esslinger, Linda Quinn, Sami Sampat, Marijo Otero-Lobato, Wim Noël, Anja Geldhof, Nicole Herijgers, Sarah-Jane Reeder

Publikováno v: Journal of pharmaceutical health care and sciences. 8(1)

Introduction In the European Union (EU), a Risk Management Plan (RMP) is submitted as part of the dossier for initial marketing authorization of a medicinal product or with an application involving a significant change to an existing marketing author

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a7dcde2718b596777c170ab12bc77e4d
https://pubmed.ncbi.nlm.nih.gov/35509028

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