Negotiating Your Way Through the Vigilance Agreement Maze-is There a Better Way?

Corbel-Ecalard, Catherine; Kilgour-Christie, Jean; Trun, Weronika; Lewis, David J

Corbel-Ecalard, Catherine; Kilgour-Christie, Jean; Trun, Weronika; Lewis, David J.

Afiliação

Corbel-Ecalard C; Amgen Inc., Thousand Oaks, CA, USA.
Kilgour-Christie J; Global Drug Development, Novartis Pharma GmbH, Wehr, Germany.
Trun W; Bayer AG, Medical Affairs & Pharmacovigilance, Muellerstr. 178, 13353, Berlin, Germany. weronika.trun@bayer.com.
Lewis DJ; Global Drug Development, Novartis Pharma GmbH, Wehr, Germany.

Ther Innov Regul Sci ; 57(5): 1017-1029, 2023 09.

Article em En | MEDLINE | ID: mdl-37270450

Assuntos

Negociação; Farmacovigilância; Humanos; Segurança do Paciente

Palavras-chave

Contract negotiation; Glossary; PVA lifecycle; Pharmacovigilance agreement (PVA); Pharmacovigilance partnerships; Process mapping; Safety data exchange agreement (SDEA)

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Negociação / Farmacovigilância Limite: Humans Idioma: En Ano de publicação: 2023 Tipo de documento: Article

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