Project management in the regulatory pharmaceutical environment

By submitting a central procedure with the European Medicines Agency the marketing authorisation holder receives a marketing authorisation for the whole European Union as well as the EFTA states (Iceland, Liechtenstein and Norway). In this paper it is proposed that certain aspects of the agile metho...

Full description

Bibliographic Details
Main Author: Ragnhildur Nielsen 1975-
Other Authors: Háskólinn í Reykjavík
Format: Thesis
Language:English
Published: 2012
Subjects:
Verkefnastjórnun
Lyfjafyrirtæki
Project management
Norway
Iceland
Online Access:http://hdl.handle.net/1946/12945
Description
Summary:By submitting a central procedure with the European Medicines Agency the marketing authorisation holder receives a marketing authorisation for the whole European Union as well as the EFTA states (Iceland, Liechtenstein and Norway). In this paper it is proposed that certain aspects of the agile method, DSDM are incorporated within the project management handling the procedure both before and after marketing authorisation.

Similar Items