Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Mergers & Acquisitions - European Regulatory Affairs challenges to achieve a portfolio harmonization - a company perspective ***

Mireille Hertel (Abschlußjahr: 2019)

Summary
Language: English
Mergers and Acquisitions to strengthen the portfolio and to gain market reach are common practice in the pharmaceutical industry since long. The thesis describes the rationale behind such activities and how the regulatory strategy for execution has been developed. Depending on the size of the deal, the preparatory work can be extensive. Two acquisitions which have been closed within a short timeframe and the subsequent activities triggered at the involved companies are covered.
The exemplary set up of a dedicated project organization which developed the key guiding principles and the involvement of the most relevant regulatory stakeholders are described. The different regulatory strategic options are explained and linked to the most important aspects and legal requirements which fed into the decision-making process for the final regulatory strategy.
The development of the regulatory strategy and the process review to be followed is outlined and the respective implementation is exemplified by illustrating the decisions taken for two countries of major interest. Further, the external influences based on regulatory landscape changes, such as the Falsified Medicines Directive, “Brexit” and national eCTD implementation including their impact on the regulatory aspects of the implementation are highlighted.
Due to their vital importance, the focus in this thesis is laid on the most important regulatory aspects during planning and execution. Not all relevant aspects of these kind of Merger & Acquisition projects can be described, due to their complexity and the impact on all levels of an organization.
Pages: 67