Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Data and knowledge management optimization by introduction of a new Collaboration Tool (Microsoft SharePoint) in the Regulatory Affairs Department of a mid-sized pharmaceutical company

Thomas Haupt (Abschlußjahr: 2016)

Summary
Language: English
The responsibility of a Regulatory Affairs department extends far beyond the medicinal product registration process. Regulatory Affairs departments have to ensure that all company activities comply with the current law. They are involved in the entire spectrum of drug production and therefore play a central role within the life science environment. Such responsibilities create specific challenges in terms of collaboration, communication and storage of information. As the end of the blockbuster pharmaceuticals is obviously, competition is getting fiercer and strategic partner ships gain in importance, better collaboration is one of the key success factors these days.
Therefore seeking to improve collaboration internally and externally should be a major objective within the life science industry. For this reason a collaboration tool has been established in the RA department of a mid-sized pharmaceutical company. The implementation of this collaboration tool (Microsoft SharePoint) is topic of the presented master thesis.
At the very beginning of the project the needs of a typical Regulatory department in terms of collaboration were analyzed (replacement of emails as collaboration tool, data management capabilities, connect employees in different regions, etc.). Subsequently the feature list for the collaboration tool, an introduction plan and a governance plan have been developed. After introduction of the collaboration tool training has been provided to the employees. The main chapter of this master thesis describes in detail how some typical daily work processes in a Regulatory Affairs department are shifted to SharePoint.
The transition from collaborating by means of email and locally stored documents, to applying a collaboration tool like SharePoint, is then described in detail. In the second to last step of this master thesis the risk and rewards of the switchover to SharePoint are analyzed and explained in detail. Finally a conclusion and outlook for the SharePoint implementation with regard to collaboration is given.
Pages: 73