When any change is made to a product or its manufacture, the clock starts ticking on managing the compliance implications. So it’s a relief to know that GenAI offers assistance. Preeya Beczek of Beczek.COM and Agnes Cwienczek from ArisGlobal explain.
Grasping the full regulatory implications of any changes to products (planned, or reactive) requires meticulous impact assessments across affected markets. That’s to ensure continued compliance and avoid supply interruption. So the appeal of automated help is inevitable. In an industry survey last year[1], regulatory impact assessment was cited as one of the main target use cases for AI automation support by senior regulatory professionals.
So how can AI help?
Already today, pharma companies are using generative AI (GenAI) technology to hone marketing authorization applications and maintain registrations.
Regulatory impact assessment is a crucial part in the product lifecycle and a logical next target to benefit from advanced automation possibilities. Fronting any process involving a product change, the activity bears an inherent time pressure. If an urgent safety change comes in, the associated regulatory impact assessment typically needs to be performed in hours, not days.
Among the immediate considerations are:
- What did we present to the authority last time?;
- What does our label say?
- How soon must the change be implemented/within what timeframe, and along with which documentation?
All of which requires extensive searching and referencing of diverse and often unconnected sources, including manual lookup of non-indexed (unstructured) data buried in static documents.
Often the investigative work extends beyond HQ too, spanning feedback loops from affiliates about the current status and local regulations, information which may be recorded in different languages.
Following a centralized review, each country must then assess whether and when they will need to make a change (e.g. reflect it in product labeling), and update their registration/notify the relevant health authority.
- Is it a case of “do first, then tell”, for instance?
- And what of the manufacturing sites where the product is held?
- When will the change be rolled out? Will a grace period be required?
- How urgent is it: can it wait for the next print run?
Many decisions and actions will need to take place in parallel, to support forward planning; the associated safety/regulatory changes must then follow promptly.
How to proceed?
So, what next?
Consider where, specifically, the main pain points are in the wider regulatory impact assessment process and its respective stages. Perhaps focus on 1-2 particular product lines to begin with, or a given region or country.
Even expediting the initial information quest will empower teams to determine and execute next actions. The ability to automatically scan the latest regulatory intelligence in different markets, and consult previous Agency exchanges, can then accelerate next steps – or pinpoint where supplementary insights are needed.
Keep in mind through that teams shouldn’t defer to the technology to make the decisions for them. Cross-functional teams will still need to agree whether and where a change is applicable, whether it needs to be made now, or whether it can be deferred, and when it should be reported to the relevant Agency, for instance.
Finally, be sure to share the vision for embracing AI, and upskill your people. Don’t leave anyone behind.
- Agnes Cwienczek is ArisGlobal’s Director of Product Management.
- Preeya Beczek, MD of consulting firm COM, is a regulatory affairs and compliance expert, with over 26 years’ industry experience.
For more on this topic, check out Episode 3 of our Life Sciences GenAI Exchange podcast series.
[1] Survey: Unsustainable Regulatory Workloads Leave No Choice About AI Adoption, ArisGlobal/Censuswide, November 2024: https://www.arisglobal.com/media/press-release/survey-regulatory-workloads-ai-adoption/ (Full survey report at: https://www.arisglobal.com/resources/regulatory-industry-survey/ )
