Shortage reporting & other issues that good data could solve right now
At Amplexor’s BE THE EXPERT 2023 I will urge marketing authorization holders to take up the mantle and get their data in order today, because of the great many process benefits and new actionable insights they’d enjoy – tangible gains that aren’t dependent on all of the external reporting parameters being known or mandated today
Waiting for regulators or software vendors to come up with the definitive rulebook for all future data reporting requirements is a bit like waiting for a tax-office request to trigger accounts management. There will always be new compliance goals, but the real opportunity is about making good data work harder time – something Life Sciences companies could – and should – be doing right now.
The fact that Life Sciences is adopting and seeing value in structured data is a huge turning point for the industry. And, once companies can see beyond the demands of the regulations that are helping to drive this, the opportunities will truly broaden so that they can transform everything they do.
This is about so much more than adhering to the specific requirements of IDMP, ePI, CTIS, ESMP, PQ/CMC and associated global implementation projects. It is about having good-quality data which significantly improves internal and external processes – with a view to identifying new market openings, optimizing clinical trials, shortening time to market, eliminating product shortages, and managing labelling changes seamlessly and without fuss.
It’s something I’ll be delving deeper into at this year’s BE THE EXPERT event in Split.
As well as bringing us all up to date with the very latest on IDMP and other data-based requirements affecting key aspects of the R&D and marketing authorization/post-marketing product lifecycle (including safety surveillance and license maintenance), I’ll be looking more closely at some of the bigger opportunities that companies have now to transform the way they operate. This includes the way they track products, tap new market potential, and connect with and add value for clinicians, caregivers, prescribers, payers, and – of course – patients.
Stop reinventing the wheel
Taken individually, the various mandates and required data capabilities and systems, can seem daunting. Take the new European Shortages Monitoring Platform, expected to go live within two years. It’s been conceived by the European Medicines Agency (EMA) in the wake of COVID-19 related supply chain disruption and shortages – not just of immediate vaccines and treatments, but of other critical medicines as entire countries and regions went into lockdown.
The new data-driven platform is EMA’s response to the situation, intended to pre-empt and curb unexpected supply issues – whether these involve paracetamol, antibiotics, flu vaccines, or hormone replacement therapy products – through prompt reporting of emerging issues.
While functional managers and IT teams might balk at yet another reporting requirement, once companies are generating regulatory data, as captured currently in documents, they can do so much more with it. This is of value to the MAH in its own right – not just because it is a regulatory mandate. It makes sense, then, to make the best possible job of capturing and maintaining that data, to a consistently high standard.
Once companies have captured the relevant data, the next step is to structure it in such a way that it can be exchanged reliably with other systems, both internally and externally. Instead of requiring that new manual processes are invoked to enter the latest relevant data into a new system or portal, that information should pre-exist and be readily redirectable to fulfil each additional emerging need.
Ultimately, gaining visibility of potential product shortages requires simply that product data and supply chain information can be combined to provide, compile and report the relevant insight.
Tracking tangible progress
In my session at BE THE EXPERT, I’ll be walking through a range of new use cases that could be enabled relatively easily once companies have reliable, consistent, good-quality, structured data organized and ready to go.
In other words, once all of the contributing insights have been released from static PDFs (e.g. CMC manufacturing process and control information as submitted to regulators in Module 3) and exist as live intelligence that can inform other teams and fulfil new reporting demands. For instance, visibility of how many products have a certain excipient, and where a product is manufactured, could automatically flag up emerging supply issues out of China, India or any other country, if that country is in lockdown.
In my discussion, I’ll be focusing primarily on the latest developments in the EU, though I’ll also run through the latest significant moves towards data standards (especially IDMP) in other markets – including Switzerland and the US.
One message I really want to drive home is the need for Life Sciences companies to move forward with all of this with a renewed sense of urgency now. Given the broad opportunity for process transformation, and the potential for crucial new actionable insights, there is absolutely no excuse for any pharma company to be sitting back and waiting – whether that’s for Regulators to issue final instructions, or for software vendors to have exactly the right capabilities in place.
Although there may be some finer details to be ironed out, there is a LOT of groundwork companies need to do today to get their data in shape, and that needs to be happening right now.
In other words, getting control of internal data should be an absolutely priority for all companies. Certainly, talk to your tool vendor about what that might look like, but relying on regulators or the software industry to lead from the front is not the way to approach this.
It’s a bit like starting to do your book-keeping only once the Tax Office has asked you to submit your tax declaration – when really you should have been recording everything throughout the year. Why persist with the 11th-hour panic, when reliable on-demand reporting is possible today – with appropriate attention to data capture and management?
I look forward to fleshing out these themes with you in person.
- Remco Munnik is a Director at Iperion – a Deloitte business. As well as being a respected subject matter expert in RIM, eCTD, xEVMPD and ISO IDMP, Chair of Medicines for Europe Telematics group; and President of the IRISS Forum.
- At BE THE EXPERT 2023 in a session entitled, The implementation of structured data and opportunities for optimization, Remco will outline the latest developments on global implementation projects for structured data (e.g. IDMP, ePI, CTIS, ESMP, PQ/CMC, etc) and the opportunities that pharmaceutical companies have to leverage these upcoming requirements to improve internal and external processes.
- Remco will also be participating in a panel discussion, on the subject of Empowering Efficiency Beyond Technology, with a focus on the role of data governance and the need for clear data roles and responsibilities as companies enrich their information assets and make them more reliable and readily reusable.
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Managing Partner of Gens and Associates
About the author
Steve Gens (MSOD) is the Managing Partner of Gens & Associates Inc., A Life Science benchmarking and advisory firm specializing in performance improvement, strategy, regulatory information management, and organizational transition. His early career was spent at Johnson and Johnson in a variety of management positions and then transitioned to consulting where he led global Life Science consulting practices for First Consulting Group and Booz Allen Hamilton.
His organization is well known for their insightful industry benchmarks, World Class RIM industry performance standard, and thought leadership. Steve has a Bachelor of Science in Business Computer Science and a Master in Organizational Development. He is a frequent speaker, has many publications, and was named to the 2017 PharmaVoice 100 and as an innovator in the 2021 Innovations in Pharmaceutical Development™ for his contributions to industry.