IDMP Hot Topics: What was Trending in Frankfurt?

Earlier this month Informatica and HighPoint Solutions co-sponsored the Marcus Evans 3rd Edition IDMP Compliance Challenge: Hit the phased approach deadlines conference in Frankfurt.  The conference agenda was packed with IDMP compliance experts willing to share experiences, challenges and concerns going forward.  Whilst listening to the industry representatives, I noted common themes occurring in their presentations.  I have highlighted these below, starting with what I feel may be the most burning question in boardrooms:

Why comply at all?  The date keeps changing, and EMA may never enforce the regulation.

Despite many people having the same question, nobody was keen to volunteer to not comply to test the EMA’s resolve.  Some interesting opinions were presented on compliance beyond simple the risk of fines.

  • It is s not so much compliance to IDMP, but what else is going to be hung off IDMP. In future many other regulations will refer to IDMP, e.g. Falsified Medicines Directive.  This is true in both Europe and the USA.  IDMP Compliance is not a single regulatory initiative per se, but a whole new way of being regulated.
  • There is a lot of value in managing IDMP data for internal purposes. Participants were encouraged to look at the value high quality product data, and use this to draw in organizational and executive support for their IDMP projects[1].
  • It is unwise to stop your IDMP compliance project now, it is better to build on momentum but with some concessions for the phased approach. Examples of concessions included
    • Continuing with a smaller project for Iteration 1
    • Refocusing on delivering high quality data through a MDM or data governance program aligned to the scope of Iteration 1
    • Using the time to put in a strategic solution for the future where IDMP is at the heart of all regulation.

“MDM will be a game changer for the industry”

IDMP
IDMP Hot Topics: What was Trending in Frankfurt?

No – this is not my quote.  Although given my support for a Master Data Management (MDM)-based approach to IDMP, it was very welcome confirmation of the benefits MDM can bring to IDMP compliance, and the industry more broadly.  This enthusiastic support for an MDM-based approach came from Gordon Topping of UCB Biopharma.  Many other presenters explicitly mentioned MDM and the role it can play in their IDMP compliance projects. To me this demonstrates many companies are coming to the same realization that the EMA did – compliance is fundamentally a master data challenge.

Jakob Juul Rasmussen of Ferring Pharmaceuticals A/S gave some perspective as to why a framework to manage the IDMP data set is so important – it comes down to sheer volume of data.  This creates workload on two fronts:

  • Number of records that need to be submitted.

These rise almost exponentially in later iterations.  For example if 60’000 records enable compliance to XEVMPD regulation, then IDMP iteration 1 will be roughly 455’000 records.  Iteration 4 will require closer to 2 million records for the same number of products.

  • Increase in submission frequency

The number of attributes under management for IDMP will also mean that the number of changes which have to be reported to the regulators will go up.  The example showed that is the current level of data under management for XEVMPD accounts for roughly 20% of all regulatory changes, IDMP will ramp this up to the region of 50 to 75%.

jungfrau profile
Marathon Profile, or Iteration 1 to 4 effort level?

My colleagues at HighPoint Soutions like to compare the effort required for IDMP compliance across the four iterations as the same effort to complete the Jungfrau marathon.  A nice steady start, but followed by a steep climb, where the terrain underfoot gets rougher.  I don’t believe you should try either of these activities without solid preparation first.  Hours on the road in the case of the Jungfrau marathon, and building data management processes and capabilities in the case of IDMP compliance.

Focus on Data Quality and Data Processes

Ferring may have put actual numbers on the scale of the data management challenge for IDMP compliance, but the sentiment of the size of the challenge was felt by many.  Those that had progressed in their compliance projects, tended to have two main challenges they need to overcome:

  • Their data quality is not of the level required for IDMP compliance.
  • They are unable to get their data quality to an acceptable level without the participation of knowledgeable people outside of Regulatory Affairs. (Supply chain representatives in particular were mentioned)

Unfortunately nobody has yet found the silver bullet for delivering high quality data in any organization.  This is true across all industries.  High quality data can only be delivered by aligning people, process, policy, and technology across the organization.  That is, by implementing data governance and management practices in addition to capabilities supported by technology.

The really good news for IDMP groups is that with the increased digitization of our world, most organizations have already realized the value in data.  Many of the presenters indicated that senior level sponsors were receptive to messages around delivering value through high quality data.

Uncertainty still persists

A lot of discussion during Q&A and the breaks revolved around uncertainty and the lack of clear communication from regulators as to what is expected.  Information around the data scope for Iteration 1 is much clearer now, but other very important topics still need clarification, including:

  • Substances: what is and what is not considered a substance;  How to get substance data from suppliers.
  • ginas (Global Ingredient Archival System as sponsored by the FDA): How best to deploy ginas;  What will be the surrounding processes which will ensure fast registration of medicines, but not compromise intellectual property.
  • Regulatory submission processes: What will these look like in an IDMP world; How will coordination between the EMA and regional authorities work

Clearly there are many questions still to be answered before IDMP is fully embraced and funded in all pharmaceutical companies.  Beyond the uncertainty, or perhaps because of it, there was a clear trend that emerged from those companies who are moving the furthest ahead in their IDMP projects:

IDMP project teams who highlight the value of the high quality product data they will generate beyond compliance are better positioned to win funding and support for their program.

It turns out that in pharmaceutical companies, like all other industries, everyone sees the value in high quality data.  They just need a catalyst to begin (or continue) the investment in delivery of trusted, secure data across the entire organization to optimize the business value from your data.

[1] How to identify the value high quality data delivers to an organisation continues to be a challenging topic for many.  I touched on this in my last blog, and Informatica has published a paper on identifying the value MDM could deliver in your organisation.

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