Navigating stormy waters: 10 years of operation of the European Union Regulatory Network Incident Management Plan for Medicines for Human Use.

Santoro, Aniello; Caplanusi, Irina; Sweeney, Fergus; Cappelli, Benedicte; Nolan, Lorraine; Straus, Sabine; Arlett, Peter

Santoro, Aniello; Caplanusi, Irina; Sweeney, Fergus; Cappelli, Benedicte; Nolan, Lorraine; Straus, Sabine; Arlett, Peter.

Affiliation

Santoro A; Quality and Safety of Medicines, European Medicines Agency, Amsterdam, Netherlands.
Caplanusi I; Quality and Safety of Medicines, European Medicines Agency, Amsterdam, Netherlands.
Sweeney F; Quality and Safety of Medicines, European Medicines Agency, Amsterdam, Netherlands.
Cappelli B; Quality and Safety of Medicines, European Medicines Agency, Amsterdam, Netherlands.
Nolan L; Health Products Regulatory Authority, Dublin, Ireland.
Straus S; Pharmacovigilance, Medicines Evaluation Board, Utrecht, Netherlands.
Arlett P; Quality and Safety of Medicines, European Medicines Agency, Amsterdam, Netherlands.

Pharmacoepidemiol Drug Saf ; 29(11): 1343-1352, 2020 11.

Article de En | MEDLINE | ID: mdl-32954565

Sujet(s)
Mots clés

EU incident management plan; EU regulatory network; drug safety; incident review network; pharmacoepidemiology; pharmacovigilance; quality

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Texte intégral: 1 Collection: 01-internacional Base de données: MEDLINE Sujet principal: Effets secondaires indésirables des médicaments Limites: Humans Langue: En Journal: Pharmacoepidemiol Drug Saf Sujet du journal: EPIDEMIOLOGIA / TERAPIA POR MEDICAMENTOS Année: 2020 Type de document: Article Pays d'affiliation: Pays-Bas Pays de publication: Royaume-Uni

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