Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Launch of a generic medicinal product on the European market. Development of a project management strategy taking into consideration various regulatory and legal requirements, summarized in a manual

Valeska Hiller (Abschlußjahr: 2015)

Summary
Language: English
The act of launching a generic medicinal product is a very complex process. Many various departments within the pharmaceutical company need to be involved and the know-how of each of them needs to be gathered.
It is up to the project management to collect and combine all those various information and ensure each stakeholder is getting the right information to proceed with the corresponding task in order to enable a successful launch in the end.
This thesis describes one option of setting up a project management manual within a generic company for launching a hypothetical generic medicinal product to be launched on the European market.
Within the first part of this thesis a general overview with correlation to project management will be provided. The introduction to the fictive product will be given within the storyline section. During the second part the legal and regulatory framework of each milestone will be explained and a cross reference to the hypothetical product will be given in order to facilitate the understanding of the legal and regulatory context. By going through the second part various obstacles and risk should become obvious which need to be taken into consideration by the project management.
The third and last part is the manual itself including the definition of the appropriate team members to be involved, a risk evaluation and the checklists. The checklists are a listing of questions to be raised during the various milestones in order to detect potential risks.
The aim is to show relevant milestones which need to be concluded successfully to reach the final aim, the launch of a generic medicinal product across Europe. The checklists provided within the manual are in accordance with the current legal and regulatory environment for launching a generic product on the European market. They should reflect some potential risks which needed to be considered within the project management.
Pages: 71 plus 5 Annexes, pages: 6