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Regulatory Intelligence — focus on system and business process improvements

In my recent post (link), I defined Regulatory Intelligence (RI) and described roles and tasks related to it. This blog post has been dedicated to dive deeper into reflections on the importance of the RI system and the related business processes, and how to improve these.

Having a RI system and processes which are flexible and easily adaptable to changes, able to detect coming trends, as well as draft regulations and publication of regulations, are essential assets of a regulatory success within pharma. On the contrary, if requirements are just being archived in a regulatory unit, but systems and processes are not established, RI will be limited as a library of requirements. There will be no “librarian” to structure the requirements and no readers to rethink and take the information further.

Nevertheless, RI staff and the system can act as both library, librarian, and readers. However, it will be much more impactful and efficient to include others from the organisation, both within and beyond Regulatory Affairs (RA) as illustrated in Figure 1 below. RI staff cannot (and should not) be experts within all aspects of RA.

Figure 1. Regulatory Intelligence integrated in RIM system

Integrate the RI system in the Regulatory Information Management system

I advise integrating the RI system into the existing Regulatory Information Management (RIM) system, if doable. I also recommend using technology as much as possible and develop IT infrastructure and business processes that are transparent operationally and system-wise. Importantly, try to get rid of parallel IT systems, stop archiving on local drives and eliminate spreadsheets requiring manual updates. This should be the ultimate aim!

Implementing these initiatives will have multiple benefits:

  • Improve the quality of each submission and potentially shorten HA approval timelines
  • Influence on guidelines timely by having a fast-internal review process
  • Strong, transparent, and efficient collaboration and communication with the Regulatory organisation and Management
  • Reduce the amount of time used on researching and organising information, thereby freeing time for analysing and drafting strategies and policies
  • Improve audit readiness

But can other initiatives be implemented on the journey towards optimising RI? For instance, Artificial Intelligence (AI)?

Can AI be used to optimise a RI system?

Yes — for sure it can! Capturing RI information/news can be a time consuming and manual task, but AI can ease some of the more demanding manual labour tasks;

The AI possibilities are immense, as illustrated in Figure 2.

Figure 2. Artificial Intelligence possibilities in Regulatory Intelligence

Would you like to use AI to lift any tasks in RI or Regulatory Affairs in general? Please let me know which by posting a comment at the end of this post.

As illustrated in Figure 2, using AI in RI has many advantages. It could potentially free up valuable time for RI staff to spend more time reaching out externally, strengthen the network, attend events, provide review comments, write policies, assess impact, take part in executive strategy and other important RI tasks.

Technology can also be used to get impact assessments and guidelines into the RI system efficiently — it can be as an app on your digital device, easily accessible link on company website etc. It should be made as easy and fast as possible to get the input into the system and access it afterwards as possible.

Streamline RI systems and implement transparent business processes

IT systems are only efficient if they are paired up with streamlined business processes. It is crucial to develop and implement transparent and simple processes (working habits) within RA/RI (headquarters and affiliates) as well as with internal stakeholders. For instance, if local guidelines are just stored on local drives or no proper process is in place to gather and communicate RI across an organisation, it can eventually lead to a considerable knowledge gap between the regulatory “layers” in a pharma company. Such knowledge gap can potentially lead to agency questions that could have been avoided, thus causing delayed agency approvals. Furthermore, RI knowledge easily becomes person dependent if RI is only stored/assessed locally, and the right experts are not consulted during impact analysis. This is a fragile path to enter, especially in affiliates where resources are scarce, and one regulatory person might cover all aspects of RA.

To sum up: Imagine a scenario where RI was integrated with the already existing RIM system, where AI was used to obtain global RI information (documents and data), store impact assessments and process updates, link to product updates, agency interactions like Q&A and commitments, paired up with information on submission and registration document and data (Figure 1)? Couple this up with simple and transparent business processes across the RA organisation and internal stakeholders. The result is a streamlined RI-RA function, potentially freeing up time on communication, sharing across and increase transparency to the max. Smaller-scale can of course also do it, but if you are already in the process of upgrading or replacing your current RIM system, consider including RI in the process and revise current RI processes. If you are not in the process of replacing a RIM system, it might be worth looking into developing AI software for RI with interphases to current RIM system or determining whether possible RI/RA process gaps exist in the current setup. Disregarding of where you are in this process, BASE life science is eager to support you in upgrading, developing and implementing a solution that system and process-wise fits your organisation and needs.

About the author — Mette Leth Schousboe, PhD, Senior Regulatory Lead

Regulatory Consultant with passion for life science, patient centricity, and stakeholder management. Mette has extensive knowledge from the pharmaceutical industry, both within global and local Regulatory Affairs, working with several aspects of Regulatory Affairs and Pharmacovigilance, e.g. clinical trials, developing products, life cycle management, labelling, and pharmacovigilance compliance. As regulatory SME, Mette has strong competences in RA business process optimisation and implementation.

Phone: +45 31 21 64 50, email: msch@baselifescience.com

About BASE life science

BASE life science is an innovative and forward-thinking technology, product and service consultancy specialised in creating real business value from digital platforms and data. Our experienced teams are ready to help optimise your technology and business processes within Customer Engagement, Quality, Regulatory, Compliance and Clinical data management.

BASE currently operates from our offices located in Denmark and Switzerland from where we assist customers across the globe. You can safely choose us as your entrusted partner, as we will make it our goal to bring your vision to life.

BASE life science is a fast growing, fast paced consultancy focused on the life science industry.