Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Vor- und Nachteile der europäischen Implementierung über SPOR anhand des Anwendungsbeispiels der eSubmission ***

Anna von Medem (Abschlußjahr: 2020)

Summary
Language: German
In July 2012, the pharmacovigilance legislation came into force to reduce the number of adverse drug reactions, among other things through the centralized use of uniform terminology and the implementation of the ISO-IDMP standards.
In the European Union, these standards are implemented centrally by the European Regulatory Authority (EMA) and follow a stepwise master data approach called the SPOR program. SPOR consists of the four areas "substances", "products", "organisations" and "referentials". Supplementary documentation, such as the European Implementation Guide or the Target Operating Model supports the ISO IDMP implementation process in the European Union.
Concerning the four areas of the SPOR program, the master thesis focused on the areas of organizations and references, since these areas are already implemented and used productively. The thesis aims to analyze and present the advantages and disadvantages of using these two domains in the European Union using the example of two submission portals from the electronic submission area. The ISO-IDMP standards, the European Implementation Guide, and the Target Operating Model will be considered only to the extent necessary to perform this analysis.
In total, the master's thesis summarizes thirteen advantages/opportunities and thirteen challenges/risks that may arise in the implementation of the SPOR domains "Organizations" and "References". The key advantage is internationally harmonized and electronically available pharmaceutical data. However, the development as well as the integration of national ISO IDMP-compatible systems is challenging.
The ISO-IDMP standards – once fully and internationally implemented – will offer extensive opportunities for electronic data processing, including improving communication in regulatory processes between all stakeholders, enabling cross-national analysis and research. The ISO-IDMP standards thus consider the requirements of the various stakeholders and are of high importance for drug safety by enabling improved and consolidated data use over the complete product life cycle, for example in the area of pharmacovigilance, in case of shortages or falsified medicines. In the EU, these potentialities are achieved through the implementation process of the SPOR programme.
In the area of the currently used electronic application form (eAF), certain requirements are already fulfilled, such as the connection to the reference lists or the validated organizational data of the EMA. Overall, the eAF is not yet ISO IDMP-compatible, e.g. because the names of the attributes do not comply with the ISO IDMP standards. This implementation will take place in a step-by-step procedure in which the eAF is first technically converted into a web form (called "Application Data Set"), which will then be made ISO IDMP compatible during further development.
Improvements and process simplifications will be achieved using the application dataset together with the corresponding target operating models for the different use cases.
Seiten: 56
Annexes: 4, Seiten: 6