Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Simplification Instead of Complication: A Critical Assessment of Pharmacovigilance Legislation from an Industry Perspective ***

Mariam Motamen (Abschlußjahr: 2020)

Summary
Language: English
The 2012 amendments to EU Pharmacovigilance (PV) legislation were one of the most significant changes to European medicinal product legislation since the introduction of the PV requirements in 1995. As a result, the pharmaceutical industry has faced major challenges in dealing with the growing body of legislation, due to the necessary adaptations to systems and processes and significant investment of resources to provide the required documentation or implement recommendations from EMA (European Medicines Agency) committees.
From an industry perspective, it has become necessary to illustrate the consequences of this increasing difficulty to comply with legislative requirements (e.g. a massive increase in personnel costs) as well as highlight those areas where further rule adaptations are not necessary and should be avoided.
Furthermore, consolidation, clarification or harmonisation of existing legislation could potentially lead to more efficient and staff-friendly processes for the pharmaceutical industry, while maintaining the highest quality standards and ensuring the safety of the medicinal product for the patient and user. This master thesis will discuss these industry perspectives, thus its title is "Simplification Instead of Complication".
Recently, the BPI (German Pharmaceutical Industry Association; German: Bundesverband für Pharmazeutische Industrie) started an in-depth look into "PV hot topics" together with industry representatives in order to identify and analyse existing issues and challenges as well as their implications for industry. The conclusions and recommendations were published as a series of papers titled "Pharmacovigilance and Maintenance of Medicinal Products". This master thesis will select and discuss several of the PV hot topics which are causing difficulties for industry. It must however be noted that PV issues can hardly be approached in isolation as they are heavily interrelated and overlap significantly (which is partly why they represent such a challenge for industry) cannot be discussed in isolation from each other. The thesis visualizes these processes and defines their "Inputs" and "Outputs" in order to make the interfaces between the processes visible. Furthermore, the thesis highlights the challenges related to these visualised processes for industry as presented in the previously mentioned series of papers, then discusses their positions and proposals, and concludes by identifying redundancies as well as simplification potentials.
Pages: 79