International Council for Harmonisation E6(R2) addendum: Challenges of implementation

The International Council for Harmonisation (ICH) E6 – good clinical practice (GCP) (R2) addendum – was released in 2016 to encourage implementation of improved approaches for the management of clinical trials. The changes in different sections include new approaches – quality management system, ris...

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Detalles Bibliográficos
Autor principal: Bhatt, Arun
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Medknow Publications & Media Pvt Ltd 2017
Materias:
Opinion
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5654214/
https://www.ncbi.nlm.nih.gov/pubmed/29109932
http://dx.doi.org/10.4103/picr.PICR_124_17

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5654214/
https://www.ncbi.nlm.nih.gov/pubmed/29109932
http://dx.doi.org/10.4103/picr.PICR_124_17

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