Learn how leading firms are driving enhanced compliance using advanced automation to monitor for regulatory updates and built a regulatory intelligence knowledgebase.
As Life Sciences firms need to generate more efficient and consistent compliance amid ever-evolving Agency mandates, there is a real opportunity to leverage innovations in artificial intelligence (AI) and generative AI (GenAI) to drive tangible benefits in regulatory information management.
In our previous blog post, we outlined one major, emerging use case of GenAI around the intake and management of Health Authority interactions, to help Regulatory teams accelerate these exchanges, pre-empt Agency queries, deliver strong marketing authorization applications the first time.
In this article, we will examine another GenAI use case with similarly significant potential – in this case, enabling the automatic monitoring and proactive use of the latest global Regulatory intelligence to enhance marketing approval application and license maintenance processes.
Tracking Changes Amid an Ever-Evolving Regulatory Landscape
Agencies around the world are continually refining and updating their requirements. Regulatory teams are challenged with staying current with these ever-evolving regulations, particularly when Health Authorities distribute news about these updates in a myriad of ways – whether via web site posts, postal circulars, email newsletters, and more – that likely will appear in local languages.
Keeping track and ensuring compliance with these vast amounts of complex and global changes can feel impossible. This is especially true for firms that rely on teams of overstretched local affiliates that are responsible for keeping a centralized repository updated with all the latest developments in their respective countries.
For example, China’s eCTD implementation guide contains important information on how to compile, publish, and submit eCTD sequences to the National Medical Products Administration (NMPA), the Chinese Agency for regulating drugs and medical devices. The guidance is provided in simplified Chinese. Without an automated solution in place, local affiliate teams would need to manually keep track of any changes and process updates in the central repository for the global team.
But what if they could leverage GenAI advancements to streamline this and ensure better outcomes?
A New Path to Accelerating Marketing Authorisation Applications
In the prior example, if the local affiliate team in China were able to leverage optimized GenAI tools they could process changes to the eCTD implementation guide much more efficiently. It would be easier to monitor for emerging updates in any language and format from any channel, to not only capturing this intelligence centrally, but proactively flag the impact of those considerations, and expose it for further downstream consumption via the global organization’s central RIM system.
One major emerging GenAI use case advancing Regulatory operations involves the tracking and proactive harnessing of the latest global Regulatory intelligence to improve the first-time success rate, approval speed, and development of marketing authorization applications.
As Regulatory teams compile new content for Health Authorities, they can ensure that any new requirements have been factored in from the onset by simply asking their RIM system’s GenAI-enabled chatbot a direct inquiry about any recent and relevant requirements, or updates thereto. This lets them get the answers they need with minimal effort required, and without having to manually monitor communications spanning languages, formats, and channels.
Additionally, to avoid any concerns about relying solely on AI, human team members are encouraged to validate any Regulatory updates, while the GenAI chatbot provides complete links to its information sources, down to the specific document and page number, so that the findings can be verified before they are reflected and leveraged for wider use.
Encouraging Early Evidence of Efficiency Gains
There is already impressive evidence of potential efficiency gains, with initial pilots from ArisGlobal testing this specific GenAI use case in client pilots yielding 90% accuracy and 50% faster processing, alongside half the handovers of manual Regulatory intelligence lookup and implementation.
This reinforces the ability for firms to improve efficiency in capturing, processing, and distributing regulatory intelligence. Additional benefits include reduced risk of non-compliance with new or updated regulations, as well as improved clarity and faster decision-making thanks to automated summarization, translation, and analysis of regulatory changes.
Thus, this serves as another example of the immense potential available in the application of GenAI in the Regulatory domain, going beyond planned capabilities to tangible, specific use cases linked to the everyday pain points of firms in the industry.
LifeSphere Regulatory: Smarter, Connected Regulatory Intelligence
At ArisGlobal, we’re working diligently and in close partnership with our clients to showcase what’s possible – not just tomorrow, but right now.
With our new LifeSphere® Intelligence solution, we are providing industry-leading GenAI automation for smarter, more connected Regulatory intelligence, powered by our next-generation LifeSphere NavaX™ cognitive computing engine.
Ready to learn more? See how LifeSphere Intelligence is helping firms monitor for regulatory updates and built a regulatory intelligence knowledgebase to help maintain consistent compliance.
