By Niels Buch Leander, Managing Consultant, PhD
In recent years, the regulatory IT landscape has been marked by an increasingly inte- grated view on the regulatory information, and a number of trends strengthen the necessity to look at the IT landscape as a whole. In this article, NNIT’s outline of the most significant trends within the regulatory area is presented.
Europe has had its XEVMPD product data submission and is preparing for maintenance of the XEVMPD data. Europe is also first to place the next product data submission standard, called ISO IDMP, in the legislation coming into effect in 2016. However, the ISO IDMP standard is global and will be imple- mented in all regions, with the regional scope being specified in regional implementation guidelines. Lately, ISO IDMP entered the concrete roadmap for the US, with the FDA placing the implementation guideline in their technology strategy, outlined in the draft document ‘PDUFA V – Information Technology Plan’.
With the purpose of automating processes and managing the entire product life cycle, there is a movement towards further integration between IT systems in the pharmaceutical company. This integration is not just aimed at the systems supporting the Regulatory Affairs processes, such as regulatory tracking, EDMS, eCTD, but also systems supporting processes in other divisions such as Production, Quality and Pharma covigilance. In particular, there is an increasing focus on the right integration between ERP systems and regulatory tracking systems, in order to obtain a faster and more accurate overview of the regulatory impact on manufacturing. With this increased integration, there is a greater need to introduce data governance, because data generated in one system may be used with a different purpose in another system. Hence, it is necessary to locate the ‘single source of truth’ for data in the entire application landscape, and also to locate where this data is used, in order to avoid problems with different data formats and vocabulary. This data governance exercise is often run as master data management programs.
Regulatory Affairs headquarters is in con- tinuous contact with local affiliates, external consultants and other divisions. Often, the globalised setup is strengthened by insourc- ing certain parts of Regulatory Operations to low-income countries. As a result, the need for finding a viable and flexible platform for collaboration and knowledge sharing across these geographical, organisational and technological boundaries is increasing. This need is further exacerbated by a new generation of regulatory affairs managers who are used to new technological tools for sharing and collaborating. Solutions for facilitating collaborations include both extending functionalities in existing applica- tions and implementing dedicated collabora- tion tools similar to social media platforms.
The process of creating, compiling, publishing and submitting dossiers to the health authori- ties is getting further optimised operationally, becoming close to being a sheer ‘commodity’. This operational excellence will be further strengthened by the health authorities’ de- clared emphasis on electronic gateways and further development of the eCTD format. In the current atmosphere of operational excel- lence, a common shift in the submission process is to allow a high degree of manage- ment overview of the entire submission process, from an Investigational New Drug Application all the way to variations. With an increasing need to monitor KPIs, new tools are required, either by extending functionalities or reports in the existing applications or by allowing new applications (such as business intelligence tools) to look for information in the existing applications. Whereas most submissions have been planned in Excel sheets or in Microsoft Project, dedicated IT systems for managing the submissions are becoming more needed and useful, as the functionality develops.
The overview that is made possible by the submission management tools changes the submission team from being reactive to proactive.
In combination, these four trends demand a mature level of information management, with a structured and well-governed approach to information architecture that goes beyond divisions and specific applications. For this reason, it is important to encourage not just functional specialisation in the organisation, but also cross-functional expertise in assess- ing the end-to-end use of information in the organisation. ISO IDMP could, in fact, be applied as a possible data model for locating the single source of truth and for some of the critical information used in the management overview of the RA processes.