TransCelerate's Clinical Quality Management System: From a Vision to a Conceptual Framework.

Meeker-O'Connell, Ann; Sam, Leslie M; Bergamo, Nanci; Little, Janis A

Meeker-O'Connell, Ann; Sam, Leslie M; Bergamo, Nanci; Little, Janis A.

Afiliación

Meeker-O'Connell A; 1 BioResearch Quality and Compliance, Johnson & Johnson, 1 Johnson and Johnson Plaza, New Brunswick, NJ, USA.
Sam LM; 2 Global Quality Systems, Eli Lilly and Company, Indianapolis, IN, USA.
Bergamo N; 3 Clinical and Medical Quality Operations, Sanofi, Bridgewater, NJ, USA.
Little JA; 4 Global R&D Quality, Allergan-Actavis, Bridgewater, NJ, USA.

Ther Innov Regul Sci ; 50(4): 397-413, 2016 Jul.

Article en En | MEDLINE | ID: mdl-30227025

Palabras clave

QMS; TransCelerate; clinical development; clinical quality; issue management; knowledge management; risk management

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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Tipo de estudio: Guideline Idioma: En Revista: Ther Innov Regul Sci Año: 2016 Tipo del documento: Article País de afiliación: Estados Unidos

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