Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Interface Pharmacovigilance and Regulatory Affairs; Establishment of a continous IT-process for implemention of pharmacovigilance procedures ***

Dr. Ann-Kathrin Ridder (Abschlußjahr: 2020)

Summary
Language: English
The aim of this work was the implementation of continuous IT-processes regarding the interface between the pharmacovigilance and regulatory affairs department. This implementation will improve the transparency and traceability of the interface and the corresponding processes. Due to the fact that until now no interface processes have been transferred completely into the IT-system, four processes were focused on which should be implemented in the IT-system: the signal management process, a PRAC recommendation, preparation and submission of an RMP and a PSUR/ PSUSA procedure.
To summarize, four important interface procedures were determined to be integrated into the IT-system. Two of them could be completely integrated and the two other processes could be discussed with possible future options of integration in the IT-system. The integration of these important processes features a very meaningful solution for continuous, transparent, traceable and reliable processes. In addition, the key element of all these processes, the interface between the pharmacovigilance department and regulatory affairs department, has been improved regarding communication, documentation, transparency and traceability. Furthermore, the legally required overview of the QPPV to all pharmacovigilance related processes including timetable, performance, effectiveness and record management is supported sufficiently. A smart and innovative opportunity has been found for the dealing with huge amounts of pharmacovigilance data and corresponding timetables and their reproducibility and reliability.
Pages: 60