Masterstudiengang "Drug Regulatory Affairs"
Master-Thesis
CMDh-Project for Harmonisation of RMPs (HaRP): Aims and results - Survey analysis of the project for risk management plan (HaRP) harmonization ***
Rumyana Atanasova (Abschlußjahr: 2021)
Summary
Language: English
The aim of this thesis is to provide status overview, pain points and the way forward in the project for the harmonisation of the risk management plans (HaRP). Given its importance and specific nature (e.g. product-specific), sometimes the harmonisation of the RMPs can be a formidable challenge. Therefore, the purpose of the thesis is:
- To frame the challenges and weaknesses in the harmonisation of RMP.
- To examine the available documents and guidelines for future development, in line with the harmonisation process.
- To provide tangible actions to deal with the problem by analysing the status quo.
The thesis begins with a brief history of the RMP, its structure, role, goals, and the status in harmonisation. Notably, the role of the RMP to minimize and/or avoid the occurrence of serious adverse reactions in patients taking particular drug, the continuous monitoring and management of the risks associated with it. As such, the RMP is an essential instrument to ensure the safe use of a medicinal product and its continuous improvement.
The objective sought by the harmonisation project of the RMPs is to apply consistency and transparency of products with the same active substances for which marketing authorisations have already been granted with different RMPs in place. Prior to the introduction of the HaRP, many differences in the RMP for the same active substance were identified, which put a heavy burden on the pharmaceutical industry and increased the workload.
On the practical aspects of the thesis, I have conducted a survey among the pharmaceutical companies in Bulgaria about the extent and degree of harmonisation. Furthermore, a stocktaking of the experienced pain points to afoot and framed the desired direction to attain. As an outcome of the analysis, multiple improvement proposals have been identified for the way forward.
Harmonising the RMP plays a fundamental role as essential enabler, which will save time, apply consistency, and provide multiple benefits to the efficiency in the overall process.
Pages: 75, Annexes: 3