INTEGRATION OF ICH GUIDELINES IN EXISTING MANAGEMENT SYSTEMS FOR (BIO)PHARMACEUTICAL COMPANIES

Research output: ThesisMaster's Thesis (University Course)

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@phdthesis{1ed0952b941f4ef18869d79213a91e62,
title = "INTEGRATION OF ICH GUIDELINES IN EXISTING MANAGEMENT SYSTEMS FOR (BIO)PHARMACEUTICAL COMPANIES",
abstract = "This work describes an approach for the implementation of ICH guidelines Q8 to Q11 in a generic management system for pharmaceutical companies. Special emphasis is given to emerging topics that are introduced in these guidelines like Quality by Design. It is described how the approaches can be employed and succesfully implemented in the organisation.",
author = "Stefan Leitgeb",
note = "embargoed until null",
year = "2011",
language = "English",
type = "Master's Thesis (University Course)",

}

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TY - THES

T1 - INTEGRATION OF ICH GUIDELINES IN EXISTING MANAGEMENT SYSTEMS FOR (BIO)PHARMACEUTICAL COMPANIES

AU - Leitgeb, Stefan

N1 - embargoed until null

PY - 2011

Y1 - 2011

N2 - This work describes an approach for the implementation of ICH guidelines Q8 to Q11 in a generic management system for pharmaceutical companies. Special emphasis is given to emerging topics that are introduced in these guidelines like Quality by Design. It is described how the approaches can be employed and succesfully implemented in the organisation.

AB - This work describes an approach for the implementation of ICH guidelines Q8 to Q11 in a generic management system for pharmaceutical companies. Special emphasis is given to emerging topics that are introduced in these guidelines like Quality by Design. It is described how the approaches can be employed and succesfully implemented in the organisation.

M3 - Master's Thesis (University Course)

ER -