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Inspections to VICH-GCP studies: EU Country Implementing Inspections of Field Investigational Sites



Introduction: Guideline 9 of VICH was implemented in 2001: the Good Clinical Practice [GCP] guideline has been implemented by industry for field investigational studies in order to obtain marketing authorisations in Europe and other markets . While audits of clinical studies are the responsibility of the sponsor, inspections were not implemented by regulatory authorities in Europe during clinical studies at the investigational sites. The emphasis has been to review the study processes within the Marketing authorisation procedure. The Hungarian Authorities have now begun undertaking veterinary clinical study investigator site inspections. This publication reports on the experiences made during such inspection.

DATE » 22.01.2016

AUTHORS » Klaus Hellmann, Miriam Haas, Claudia Schneider

PUBLISHED » QUASAR, Issue 134, 4th International Edition, January 2016.


Publications in Magazines - 21.11.2024





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