Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

IDMP - a business driver for implementation of a company wide master data management system in pharmaceutical companies

Dr. Florian Haberl (Abschlußjahr: 2018)

Summary
Language: English
Digitalization is one of the main challenges nowadays in all kind of industries and also in pharmaceutical companies (for details see chapter 1.3). In pharmaceutical companies the exchange of data between Regulatory Affairs and other departments is mainly a manual or paper based process which needs to be transformed to a digitalized process.
With the finalization of the ISO IDMP standard [5] it is clear that ISO IDMP will be one of the underlying standards of the data model for the pharmaceutical industry. Also the clear commitment from EMA to use IDMP for all future communications with the MAHs [14] and the start of the SPOR project [33] are a clear indicator that ISO IDMP will be the standard of the (near?) future.
Within this master thesis the actual status of the different IT systems in pharmaceutical companies was described and the status of the ISO IDMP / SPOR implementation of EMA was discussed. To comply with the requirements of IDMP EMA submissions a huge amount of data need to be collected across the whole company (for details see chapter 1.8). This is not possible with a standalone Regulatory Affairs system anymore (For xEVMPD submissions to EMA it was possible).
A major change is needed within IT infrastructure of the companies. The best solution is to establish a company wide Master Data Management (MDM) system based on the ISO IDMP terminology (for details please refer to chapters 1.6 and 3). With the usage of this data model in the complete company for all IT systems and their interconnection with MDM it is rather simple to collect all necessary data for the submission to EMA or any other National Competent Authority in the future.
IDMP is not another (doubtful?) agency requirement which need to be fulfilled but is the starting point and one of the main business driver for the digitalization of pharmaceutical companies in general especially on the company functions Pharmacovigilance, Regulatory Affairs, Manufacturing (Operations) and Clinical. Essential examples have been described especially for the link between Change Control and Variation handling (see chapter 4.3 for details).
As described the implementation has also several advantages for the company itself especially in the field of data analysis, data transparency and process streamlining (see chapter 5.4).
Pages: 65