EMA’s latest shift in its IDMP implementation guidance has been well documented. At the coal face, it’s causing all kinds of confusion as pharma companies try to figure out what they should do now. At Amplexor BE THE EXPERT 2022, I will draw on my ‘insider’ knowledge as an active participant in the EMA SPOR Task Force and member of the EMA PMS Process Focus Group, to provide some welcome clarity.
As most Regulatory teams know well, EMA has made some last-minute adjustments to its EU IDMP implementation plan, meaning that the Digital Application Dataset Integration Project (DADI) interface rather than FHIR will serve as the means for making data submissions – at least initially – once these become mandatory just under a year from now.
To many, the move may have felt like another challenge they could do without- not least because they have already invested so much in their IDMP SPOR-based data preparations. Unsurprisingly, these teams are wondering what to do next.
Before EMA announced this latest change, teams understood that they would need to collect all of the structured data around registered products, in the designated format, and get this submission ready, to be sent to the agency at the same time as any variations or initial marketing authorizations. This was – and remains – a huge deal.
Now, however, companies will fill out a form that’s essentially a structured data version of the form that their Regulatory teams have been filling out for years. This will ease some of the pressure to be ready for a full data ‘exchange’, while allowing progress with data-based submissions.
It’s understandable then that, after initial anxiety at EMA’s new direction, some companies have seen this as a chance to take their foot off the gas.
An investment in data is an investment in the business
Yet, the need to collect, prepare and maintain structured data remains critical. First, because EMA still very much intends to implement its Product Management Service (PMS), which is where this data will ultimately sit. Indeed, DADI will be pulling in data from these PMS records. So there remains a vital data enrichment and correction process that the industry will have to go through – for all current and future product registrations and variations.
Second, as we all know, getting all of this data in order and in great shape has much broader value than merely checking a compliance box. This isn’t just about being able to dash off a report and hand it to the person who’s going to fill in this this application form. Longer term, this data will be imported into the PMS database, via a connector once developed. At which point the role and value of that data in its dynamic form will grow considerably, transforming not only the way Regulatory processes are managed but also broader access to reliable, current product data by healthcare providers and patients.
In the meantime, companies themselves have numerous potential internal use cases for all of this data in its clean, comprehensive, standardized and accessible form. These include the not-to-be-underestimated opportunity to tighten up and improve the CMC change/variations management process, something most organizations continue to struggle with.
Once rich, current product and registration details can be reliably managed as structured components in a database, it will be much easier to see and manage what’s approved in the market at a given point in time, which will reduce risk and inefficiency for pharma companies, and ultimately improve public safety and public health.
So, what now?
Analytics will help highlight what’s possible – and what’s missing
Many organizations are starting to pull registration data into data lakes and analytics platforms, where they’re able to view the data from a registration perspective. This gives them a feel for the broader possibilities – the chance to see at a glance what they have registered where, how this compares with what’s being produced and released to markets, and the associated commercial performance. Which license costs might not be worth continuing with, for instance? Or where are opportunities being missed?
It’s as companies begin to see what they have that they will start to really imagine how far they could take this, strategically as well as operationally for the business. That’s a big benefit that organizations are going to start to see as they start to master this data – at least for Europe, where this initial IDMP drive is focused.
The ability to tie registration details into pharmacovigilance is another important opportunity that I’ll be talking more about during my BE THE EXPERT session. I’ll also be comparing the findings from my own conversations with industry stakeholders with the latest Gens & Associates World-Class RIM research (being unveiled at the event).
At a practical level, I’ll be discussing the importance of rigorous data governance, and looking at some specific actions companies can take next to optimize their ROI from their ongoing investments.
Attendees can look forward to an illuminating session full of helpful takeaways. See you there!
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Principal at K2 Consulting
About the author
Kelly Hnat is a leader in RIM and IDMP with over 25 years’ experience in the biopharmaceutical industry leading IT, RIM, and Regulatory Operations organizations. Kelly is a globally recognized expert in IDMP and is a key subject matter expert supporting the EU implementation of IDMP as a member of the EMA SPOR Task Force, the SPOR PMS sub team, and the SPOR EU Implementation Guide Focus Groups. Additionally, she is a member of ISO TC215/WG6, is a member of the Core Research Team for the Gens & Associates World Class RIM survey, and serves as President/CEO of IRISS Forum, a global nonprofit organization that brings together industry, vendors, and health authorities to address topics related to submission standards. Kelly leads K2 Consulting, a boutique consultancy that provides business process, organizational strategy, and technology strategy services for Regulatory Affairs organizations.