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00:00:01
PMS: Mind the (Data) Gap
23 Plays15 hours ago
Welcome back to the Ennovation Podcast, where we bring you the latest trends, insights, and expertise in life sciences and regulatory affairs. This time, we're joined by Michiel Stam, management consultant and regulatory lead at MAIN5, to explore what it really takes to prepare for EMA’s PMS data enrichment deadlines.
Michiel’s top resources:
- Take the first step to readiness. Download the IDMP Starter Pack
- Is your portfolio ready for enrichment? Access the downloadable PDF timeline
- Understand long-term alignment strategy. Watch the PMS Data Alignment webinar
Bonus:
- Want PMS-ready data without overhauling your RIM? Learn about Ennov EASI
Recommended
Transcript
Introduction to The Innovation Podcast
00:00:00
Speaker
Welcome to the Innovation Podcast, your go-to source for the latest trends, insight, and expertise in life sciences and regulatory affairs, all in one place. At Enove, we're dedicated to empowering life sciences organizations with innovative solutions to navigate the complexities of their industry.
Alice's Background and Episode Focus
00:00:18
Speaker
I'm your host, Alice, and I've worked in regulatory operations for eight years. My background is in regulatory information management, and I bring my experience working in large pharmaceutical companies to supporting clients here at Enove.
00:00:30
Speaker
This time on innovation, we're going to dig into some practical experiences preparing for IDMP and PMS compliance with Mikheil Stam, regulatory lead at Main 5.
Importance of PMS Compliance
00:00:41
Speaker
We've spoken about IDMP before and the EMA's product management service platform, PMS.
00:00:46
Speaker
One thing I've been saying a lot to clients is that the deadlines for PMS enrichment are closer than we think.
Introducing Mikheil Stam and His Expertise
00:00:52
Speaker
and that companies really need to start thinking about preparation sooner rather than later.
00:00:57
Speaker
But what does that preparation actually look like? Well, Mikhil Stam is here to share his experiences working with pharmaceutical companies as they prepare for PMS compliance and talk to us about what we think might be coming next.
00:01:09
Speaker
Mikhil, thank you so much for joining us. and Perhaps you can introduce yourself. Hi, Alice. Thank you so much for having me on the podcast today. Just to give a brief introduction, my name is Mikhil Stam.
00:01:21
Speaker
I'm with Main5 and I'm working from the Netherlands, so working as a management consultant, also one of the regulatory team leads at Main5. And I've been active in in regulatory affairs operations for nearly 20 years.
00:01:36
Speaker
And since 2012, I've had a strong interest in IDMP, XE, VMPD, So at Main5, we support life-size organizations with organizational change, also bringing a more implementation-focused approach to digital transformation.
Challenges in IDMP Alignment
00:01:54
Speaker
And that also includes a lot of work on IDMP. um For example, helping companies to adopt the the standards, defining the related business processes, establishing data management best practices, also working on the implementation and configuration of supportive systems.
00:02:14
Speaker
And we also help to define them implementing effective data governance and and master data management frameworks. And these activities often also go along with organizational change management and and training services that we also provide to ensure successful adoption.
00:02:32
Speaker
It's fantastic to have you. So I'd love to start with just a quick recap. Where do most companies that you work with currently stand in aligning their IDMP data to meet those new PMS requirements?
00:02:45
Speaker
We see companies are at very different stages in their journey. ah Many began performing the initial gap analysis already when the first version of the implementation guides became available, and that's been already a number of years ago. um so in those early days, these these efforts led to all kinds of initiatives when it comes to data quality improvement, some targeted enrichments in their RIM systems.
00:03:10
Speaker
But then we also saw over time that the momentum was often lost ah due to delays in the implementation timelines, also due to not having clear and detailed guidance yet on all the aspects that need to be addressed. um So this eventually resulted in many companies to pass or to to scale back ah their activities.
00:03:35
Speaker
Yeah, that's definitely something I've seen. and The deadline changes in particular, I think have had a really huge impact on preparedness efforts. You know, when you've got limited resources, you need to be ready in time, but you don't want to be ready too early and then have to maybe redo things.
00:03:50
Speaker
How have you found those early starts and then the subsequent pauses have affected companies readiness today?
Strategic Data Governance for IDMP
00:03:57
Speaker
Yeah, as you said, so we've seen that initially this resulted in in companies being becoming more conservative when it came to planning any new initiatives. But now with PMS Live and also having really actionable deadlines in place, there is a renewed urgency that we can see.
00:04:14
Speaker
ah Companies are focusing again on data quality improvements, now also aligning internal data with the data that has been migrated to bs and also working on the additional data enrichments, additional data that has been requested for enrichment in PMS directly.
00:04:33
Speaker
Most data in PMS still comes from XCVMPD, so that has been in place since 2012 now. ah Also for centrally authorized products, some of the data coming from Siamet.
00:04:45
Speaker
So even though a large portion of the data was already migrated, PMS data granularity and the structure doesn't really match XeVMPD, also doesn't really match internal records from that perspective.
00:05:00
Speaker
And then also having data coming from Siamat adds further complexity since you don't have any direct control over these records and then have to raise a change request to the email
Holistic Data Management and Technical Requirements
00:05:11
Speaker
service desk.
00:05:12
Speaker
There are yeah various reasons why why data in PMS that is originating from XeVMPD is not always ready to use yet and also not aligned yet with the data that companies have internally. Yeah, it's definitely a challenge when you have data flowing from, from those various places. And I mean, Siamed is an EMA system. So it's kind of explainable that we're not aligned with our RIM systems to Siamed. Right. But then i think even a lot of people's RIM systems, it's not necessarily aligned with XCVMPD, right? It's, there's always a little bit of variation there, a little bit of back and forth.
00:05:49
Speaker
Um, So where do you see those kind of big gaps between the internal RIM data and the PMS content? Well, as you mentioned, even XCVMP data today is not always aligned. There are historical issues that have been migrated to PMS often due to not consistently following up on the XCVMP data acknowledgement process.
00:06:12
Speaker
Definitely been guilty of that one myself. I think many companies are and, uh, Yeah, they they were expected to either reflect the changes you email made internally or challenge them, but this process was not well followed as it was very inefficient and time consuming and really difficult to manage at scale.
00:06:33
Speaker
ah Also, not too many implications if you didn't follow up. Another factor there was that the changes applied were done selectively by IMA. It was, ah let's say, yeah sometimes to a single authorized product without extending that same change across all the other related registrations for that product.
00:06:53
Speaker
And that actually introduced further inconsistencies. And meanwhile, that process has changed. So it's it' it's great to have that ah now being improved. But yeah, a lot of these legacy issues still remain.
00:07:06
Speaker
And then the other challenge is, I would say, related to the source documentation that was used. So XCVMPD relying heavily on on a literal transcription from local product information.
00:07:19
Speaker
And over time, those documents may have started to diverge between markets using different terminology, especially for older products. Also, especially, for example, when registered through the national procedure.
00:07:34
Speaker
And this led to further inconsistencies across product data across registrations for the same product. Yeah, again, I've we've worked with companies with really old legacy products. And like you say, the you know in theory, the product data should be consistent. And then when you look at the SMPCs, actually there's a huge amount of divergence there, which has been fine for XCVMPD, but it's definitely more challenging in that kind of data-based PMS world.
00:08:02
Speaker
So when you've got that kind of legacy
Evolving Role of IDMP and PMS
00:08:06
Speaker
divergent historical documentation, how can companies start reconciling the regulatory data with that?
00:08:13
Speaker
Well, the good news is that towards the end of last year, IMA made an important change to the XCVMPD requirements by allowing also a module three to be used as a reference for the product composition.
00:08:27
Speaker
This information is typically much more consistent across the different registrations, so it it really supports a more harmonized presentation of data in line with also the the objectives that are described in the IDMP implementation guides.
00:08:41
Speaker
Still though, for companies it also means a significant effort. So both the internal records, but not only the records, also the internal processes must be adapted to this. Yeah, I'm really hoping that those module three documents being allowed is going to make some of that harmonization process easier. And I've generally found those are a bit more consistent than the SNPCs.
Integration of Regulatory and Supply Chain
00:09:02
Speaker
and What areas of data do you think are going to be the most difficult to harmonize across countries and across systems? ah So besides the qualitative, quantitative composition, indeed, then... um We also see some challenges resulting from the migration itself.
00:09:20
Speaker
It's so companies have reported duplicate medicinal product entries, missing products in PMS, seen mismatches in various data points like the marketing optimization status, for example, having incorrect ah main numbers assigned at the back level, inconsistent or incomplete ingredient data, ah errors in the product naming convention. So that those are just examples, quite a few examples already where we see further data corrections and alignment is required.
00:09:53
Speaker
And Ima has worked very hard to address these and given him the The scope of this transition,
Conclusion and Next Steps
00:09:59
Speaker
and and it's really impressive to see what they have accomplished.
00:10:03
Speaker
Nevertheless, the, the system and migrated data is not yet error-free and this represents additional challenges for, uh, for the industry. Yeah, it's definitely, it's one thing to align your, your data internally and your documentation internally, but if what you're aligning against is sort of a bit of a moving target because of these data quality issues with, with PMS, I can.
00:10:26
Speaker
Imagine that makes things substantially more difficult, um particularly if you've got a very large complex portfolio. So given those instabilities, shall we call them, what do you think the best timing for companies to act, you know, particularly with those deadlines coming up? um But as we've said before, you don't want to go too early, perhaps. So how do you balance those two things?
00:10:50
Speaker
That is a key question that many companies struggle with because it's... The million dollar question, huh? As you said, RIMS PMS data alignment is a very laborious task, therefore also costly.
00:11:02
Speaker
So ideally done, performed right the first time and done and done only once. But the landscape is complex. On the one hand, we have the the firm deadlines that are in place for the initial data enrichment activities to be completed by the end of this year.
00:11:17
Speaker
so So I would say companies that have not yet begun, they run the risk of falling behind. On the other hand, yeah companies have become conservative. They are waiting for PMS to be fully stable with all the requirements also being crystal clear.
00:11:32
Speaker
um Organizations would prefer to wait and consolidate in all their updates and enrichment efforts into a single efficient initiative. Yeah, that's probably not possible if you want to meet those deadlines that we currently have in place.
00:11:48
Speaker
I mean, would you say that you think there is going to be a point at which it is going to be stable and you could do that kind of effort? Because increasingly it feels to me like waiting for that is sort of waiting for something that isn't going to come.
00:12:01
Speaker
um And we have to maybe be a little more comfortable with the fact that these things are going to change. Absolutely, i think that's inherent to the the iterative implementation approach that EMA is following.
00:12:17
Speaker
So you definitely have to be flexible. You have to also consider there is no long-term roadmap yet for the scope expansion. More detailed requirements for data are being requested along the way.
00:12:30
Speaker
So it makes it hard to do strategic planning. We're also in a transitional phase. So eventually PMS will replace XEVMPD fully. At same time, we don't know the final target operating model for PMS. The exact timelines are still unclear.
00:12:48
Speaker
And so this this lack of visibility makes it hard to do long-term planning. So alignment is definitely not a one-time project. It's a scalability challenge. And sustaining that alignment and preserving data quality also whilst managing changes over time and also at scale, that that also requires robust, ah supportive technology.
00:13:11
Speaker
And I think for many of us who work in regulatory affairs, particularly, we really like certainty. We really like rules and clear roadmaps. I think it's a bit of a mindset shift, isn't it? As much as anything else of getting used to an iterative implementation, like you say, where things are moving and we need to build that level of flexibility into our planning process.
00:13:36
Speaker
So, How do you think we kind of future proof our data alignment and ensure that long-term consistency while we know things are changing? To be successful in this, I think companies need to do more than, let's say, a tactical data cleanup.
00:13:51
Speaker
They also need to have a solid foundation of of well-governed data in their RIP systems. That is also including their product master data. Too often we have seen companies doing enrichments and then see their efforts go to waste.
00:14:09
Speaker
The root cause is often a lack of sustainable processes, definition of ownership, having oversight. So I would say these one-shot enrichments are to be avoided without any clearly defined data ownership and lineage and clear data definitions. And the the outputs will remain inconsistent or or incomplete.
00:14:31
Speaker
And when this trust in the data is lacking, then an organizations struggle not just with PMS requirements and IDMP, but in general also so with the reuse of this information for for other business use cases.
00:14:44
Speaker
And to elaborate a bit more on this point, it's important to also consider the more strategic dimension of IDMP as most companies recognize IDMP not only as a regulatory obligation, also as a driver for broader enterprise data initiatives, also facilitating cross-functional integration, for example.
00:15:06
Speaker
So I think real success would come when organizations start to aim for creating this value beyond the compliance requirements. Yeah. I remember probably earlier in the IDMP journey when we were talking a lot about IDMP as an opportunity and sort of being able to harness all that data that was going to be required for IDMP to actually drive strategic change organizationally. So i think you're right. If you get those processes in place and you know, you can trust the data, then actually it can be so valuable to beyond just complying with a checkbox of PMS for EMA.
00:15:45
Speaker
ah How do you, think companies can really realize that value beyond just the compliance hoops that they have to jump through? Well, if we look at today, then I see readiness activities are still primarily focused on ah addressing the now the immediate and then near future demands.
00:16:05
Speaker
sourcing data from regulatory approved documents. 80-90% of the IDMP data can be sourced from these documents today, with also the ownership primarily resting with regulatory affairs, regulatory CMC.
00:16:19
Speaker
And although this this structure meets the current demands from EMA for the scope of iteration one data, for the authorized human medicinal products. Yeah, it's also mainly driven by this regulatory mandate to fulfill those immediate and near future compliance needs. So i would say if we look at the underlying data, then a large portion does not originate in regulatory.
00:16:41
Speaker
and as IDMP will become more matured and also data will increasing increasingly come ah from other functions. I think about extension in the area of clinical particulars coming from r and d and clinical medical affairs, information about batches coming from manufacturing, packaging data from the supply chain. Yeah, I think that supply chain integration to me feels like quite an obvious next step. um We're already starting to see things like data carrier IDs, which obviously require that supply chain integration.
00:17:16
Speaker
I agree. and then And then even if we consider today, we only talk about the authorized medicinal products and then considering ISO also covers an investigation on medicinal products, then we will even see that the majority of the data is primarily owned by R&D clinical and clinical supply functions.
00:17:34
Speaker
So they they generate that data already long before any regulatory submission and then are also often best positioned to to ensure the data quality from the source. and I think having this foundational data, control over this foundational data is critical for any later stages during the the product lifecycle.
00:17:55
Speaker
Definitely. And when you talked before about sort of processes and data ownership and those ongoing cleanup efforts rather than kind of single big bang projects, I think that's the clinical data is such a good example of that because it really does have to be maintained by the clinical teams, doesn't it?
00:18:12
Speaker
Absolutely. Yeah. Yeah. So how can a function like R&D and like those clinical teams really be empowered to take a leading role in managing that early stage product data, particularly when they haven't had to have those responsibilities before?
00:18:28
Speaker
Yeah, I would say as the source of a lot of ah crucial IDMP data, then these functions are naturally positioned to to steer the end-to-end process from from early development to authorize product data.
00:18:41
Speaker
So with with involvement of R&D Clinical, we we can embed that data quality at the source. So this will enhance the efficiency, the consistency, also the accuracy across systems and functions.
00:18:55
Speaker
And it will also ensure that the compliance can be built in from the start. So today we do see a lot of need for downstream rework, manual interventions. So all of these activities at later stages can then be minimized and i ideally avoided.
00:19:13
Speaker
So just to summarize that, to be successful, companies should look at shifting the the data ownership model, embedding data quality management at the source, and also supporting end-to-end traceability of this data across the product lifecycle.
00:19:27
Speaker
And this will then greatly enhance their operational efficiency, but also facilitates the cross-functional collaboration. And this is also in line with what is often part of their broader strategic goals for digitization.
00:19:43
Speaker
And then having well-defined data governance with supportive processes is a prerequisite. So there must be a clear definition of the data origin, data ownership, contributors and people responsible for the maintenance of the information to, to guarantee the quality and also build in trust.
00:20:02
Speaker
So we talked a little bit there about the data, the processes, the people, but I mean, obviously I'm biased here, but i always think that the tools have a pretty important role to play there as well. So what do you think is required to be successful from that kind of technical perspective?
00:20:20
Speaker
From a technical perspective, I see many companies struggle with ah lack of having transparency and oversight of their data. So, for example, it's very difficult to compare your internal RIMS data with what what data is currently PMS.
00:20:36
Speaker
Systems are often limited, might be inefficient. Often we see functionality offering a side-by-side comparison on on a product-by-product basis. But this is not reflecting how companies manage their portfolios. So I would say what you need is a system that can can continuously monitor any discrepancies being introduced across the portfolio, then automatically flag these inconsistencies when they are detected.
00:21:04
Speaker
So that as such they can provide actionable insights for data managers to work on the resolution. So any ad hoc manual comparisons I don't believe will be sustainable. So without automation and further intelligence, then the alignment becomes like a never ending fire drill.
00:21:26
Speaker
Yeah, I can definitely see that particularly as we move towards having to submit data for the whole portfolio. If you've got a really large portfolio, the automation opportunities there would certainly be of benefit.
00:21:40
Speaker
And at the moment, obviously a lot of the work that's being done is by necessity being done through the PMS user interface. So As we move towards a world where hopefully the right API becomes available, how do you see that playing into the technical needs um but for this work?
00:22:01
Speaker
This, yeah. So if we need to define how to actually update information in in PMS, and even though we have these deadlines by the end of the year in place for the enrichments of data on manufacturers, the business process, business operations.
00:22:18
Speaker
structured back size information, then the right API is only expected by the end of And at that time also, vendors still must have the opportunity to take the time to integrate it. Companies have to implement and validate these these changes.
00:22:34
Speaker
So in reality, it means many companies will not have the full write capability. ah very late this year or early next year. Also the scope of the API is still limited by the antiquity. So the full API from EMA side will anyway not be ready this year.
00:22:54
Speaker
So that raises another key question again. Should we now start manually updating PMS? Should we use the build update functionality and the product UI, the MS UI, or should we wait still for this full API integration? And I think the i right answer depends on the portfolio size, on also the vendor capability, and also the the risk tolerance that you are willing to take.
00:23:21
Speaker
I think one thing is certain, and that is that internal to PMS data comparison, that should start, that should already be underway. So even when not yet applying these changes in PMS, you should really be working on this today.
00:23:37
Speaker
Yeah, I would agree. And that's certainly something I've been telling people is that even if you haven't yet nailed down your method for submitting that data, actually gathering and maintaining that data is a challenge of it in and of itself and a challenge that you'd be probably best placed to submit if you've tackled that one first and you're really confident in the data that you've got.
00:24:00
Speaker
And, you know, as we've said many times, one of the difficult things about the way that the EMA has approached IDMP is that it isn't that one-time effort. PMS requirements are going to evolve. So if we can try and look into the future a little bit, if you had to put money on it, what do you think is likely to be next for PMS?
00:24:20
Speaker
I think in general, we will see IDMP playing an increasingly more prominent role in life sciences. Initially, when it comes to further scope expansion, but also with additional PMS use cases being implemented at EMEA.
00:24:38
Speaker
Also the adoption in other regions worldwide. So on the short term, I expect to see further expansion in the scope of PMS data requested. EMIR reviewing currently supportive reference terminology for the shelf life, storage conditions, materials in RMS. So these fields are likely to be requested next.
00:24:57
Speaker
Announcement on this is expected soon around the end of Q3. So that's a good one to keep an eye on then is that but supply chain integration and as you say, shelf life and storage conditions.
00:25:09
Speaker
Yeah, we see indeed, we expect an increasing in volume of data to origin originate from outside of regulatory. IMA has already signaled a strong intent to tighten the integration between the regulatory domain and the supply chain to and with the overall aim to improve the availability of medicines.
00:25:29
Speaker
and During the Medicines for Europe conference this year, Imer Cook already stated, what's the the point of getting new therapies approved if if subsequently these products failed to to reach the patients due to unavailability.
00:25:42
Speaker
ah So I think she's very right on that. Since February, we have PMS supporting ESMP patients to monitor these shortages, also including data on on the marketing status, which is typically also not coming from regulatory directly.
00:25:59
Speaker
BMS will also replace XCVMPD's role as the source of information for the EMVS, for the Falsified Medicines Directive. And then we have the EPI initiative for which EMA also published their reflection paper in April this year, where, as you mentioned, the use of data carrier IDs plays a prominent role as to to link electronic product information with the data and PMS.
00:26:25
Speaker
And even though a data carrier ID today is still optional, then we can expect this to become required also not too long from now. And also, this is another good example of data coming from from manufacturing and supply.
00:26:39
Speaker
And it's, I think another case where I've certainly experienced personally the challenges of trying to integrate data that comes from outside of the regulatory domain with the data in the regulatory domain.
00:26:53
Speaker
So what do you think are some of the important things to consider when you you're looking at managing that data flow from outside of regulatory, through regulatory perhaps and and into systems like PMS?
00:27:06
Speaker
Yeah, indeed, for providing the the data carrier ID, yeah for example, then you will have to have a connection between your registered packaged medicinal products and your RIM system. On the other hand, your packaging material data in ERP.
00:27:20
Speaker
In some cases, some companies already have such a linkage, ah usually in the other direction, to to provide regulatory data, let's say on approved shelf life, storage conditions to share that with Manufacturing, we also see usually ah these processes for for matching regulatory packaging data with the SKUs is still not fully automated, largely manual.
00:27:45
Speaker
I think IDMP here provides a framework to enable bidirectional integration and increasing both transparency and efficiency. And this is where we also see IDMP beginning to deliver its full potential, not just to meet compliance, to be compliant, but also ah for transformation, to to enable more robust traceability, facilitating the the collaboration between these these functions, ah supporting better decision-making overall. And this ultimately benefits all the stakeholders involved. So that includes not only industry regulates, but also the patients.
00:28:25
Speaker
And I find it very encouraging to see that regulatory affairs is stepping into this, into this expanded cross-functional role, helping to to lead a transformation where data processes get aligned and where value creation across the company is taking place.
00:28:44
Speaker
So I'm really excited to see this shift and also to now be a big part of that. Yeah, me too. I've always felt that regulatory, particularly, we kind of have this horde of data and we sit on it like a dragon and we don't really want anyone to touch our data or do anything too big with it. So it's really exciting to see that transforming into that kind of bi-directional flow where actually we're all working together, managing this information across the whole company. And like you say, really realizing the value of that for our companies but also for our patients uh I think that's something that really motivates me in my work and motivates I imagine a lot of us who work in the pharmaceutical world so thank you so much Mikhail this has been absolutely fascinating I've loved talking IDMP with you um and i I'm sure we'll have more opportunities to talk IDMP again because it's certainly not a topic that's going anywhere
00:29:40
Speaker
For more information from McKeel, you can go to www.main5.de. Thanks for tuning in to the Innovation Podcast. At Inove, we help over 450 life sciences companies streamline compliance, enhance efficiency, and achieve their regulatory goals with our unified platform.
00:29:58
Speaker
Ready to learn more? Visit inove.com or connect with us on LinkedIn to see how we can help your organization succeed.