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Perspectives from Paris: What’s on the Horizon for 2026
32 Plays1 day ago
In this special edition, I bring you highlights from our 2025 Ennov Europe User Meeting in Paris, where I spoke with four regulatory leaders from across the industry. I asked each of them the same three questions about their biggest priorities, challenges, and innovation, so you can compare perspectives, borrow what works, and plan ahead for 2026.
Our Top Resources
- Get ready for eCTD 4.0: View the upcoming deadlines
- See how AI is being used today: Read the top use cases
- Set your strategy for 2026: Download the IDMP Starter Pack
Recommended
Transcript
Introduction and Guest Lineup
Inove's 2025 User Meeting Highlights
00:00:18
Speaker
If this is your first time tuning in, we usually bring you a sit down deep dive with guests from the industry. Today, however, is a little bit different. Back in October, i was at Inove's 2025 user meeting where we get our clients together to share their experiences, hear about the latest developments in life sciences and learn from each other, all in the gorgeous setting of autumnal Paris.
00:00:40
Speaker
I took that chance to speak with four leaders from the industry.
Alice's Background in Regulatory Operations
00:00:44
Speaker
I asked each of them the same three questions so that you can compare perspectives, borrow what works and plan for what's next. I'm Alice Merrill, your host, and I have eight years in regulatory operations and a background in RIM.
Key Themes: IDMP, ECTD, AI
00:00:57
Speaker
So let's get into it. It's nearly time to wrap up 2025 and look ahead to 2026. Three themes kept coming up in every conversation I had in Paris, IDMP and data readiness,
00:01:09
Speaker
ECTD expansion and practical AI that teams can validate and scale. Fittingly, those same topics were the focus of the Innova user meeting presentations.
Industry Leaders: Introductions and Perspectives
00:01:19
Speaker
Before we get started, let's meet our guests.
00:01:22
Speaker
Yeah, this is Steve Gens from Gens & Associates. So I'm Vanessa Spurt from Main5. Hello, good morning, Alice. Thanks for for asking this questions. So I'm Stefan from Stada.
00:01:34
Speaker
Hi, I'm Tim Powell from Biogen. Now, before we look ahead,
AI Experimentation and Emerging Skills
00:01:40
Speaker
let's look back. I asked our guests, what was your biggest regulatory focus in 2025? For us doing so much research and getting a sense of where, you know, all the different, you know, large biopharmaceuticals, mid-tier, smaller companies are.
00:01:56
Speaker
um Obviously, everybody's obsessed about AI, but they really don't have their arms around it. you know There's a lot of experimentation, you know especially in the medical writing, um AI for QC routines.
00:02:09
Speaker
Probably
IDMP Implementation Challenges
00:02:11
Speaker
another big focus is organizationally, what do we do in the next two or three years? What what are the emerging skills that everybody needs to be? and you know How do we develop junior talent is really a complex question versus a simple question now.
00:02:27
Speaker
So my
Project Consolidation and ANOF Performance
00:02:28
Speaker
biggest regulatory focus for 2025 has been as a consultant the IDMP implementation and this is also related with data quality and data governance and yes just to be ready for the IDMP requirements from the EMA project and also to see the new challenges for the next steps.
00:02:48
Speaker
So ah our our biggest regulatory focus in 2025 was, so we had a huge project with ANOF that we moved and consolidated our whole landscape, the regulatory landscape to ANOF in 2024 and we went live in summer 2024. And the laser focus on 25 for us was to stabilize everything to ensure the right performance. And to be honest, with Ennof we are super happy. It's performance.
Global ECTD Standards Harmonization
00:03:18
Speaker
We had no outage and was the right focus we set.
00:03:23
Speaker
So for the biggest regulatory focus for me in 2025, I'm going to say part of what my role is on FPA with the ECTD subgroup is ah influencing and trying to harmonize ECTD standards around the world. And we've done a number of presentations to different regulators. So I think that's been a really, it's it's grown so much not just in 2025 but even in the last a couple of years. We're seeing a real increase and you can see that in the the regulations that are coming through with new regulators announcing timelines for ECCD. We have ah a huge number now on our watch list that haven't announced timelines but hopefully will do in the near future.
Cloud-Based Regulatory Spaces and AI Realities
00:04:04
Speaker
So it's great to see folks moving to a more standardised electronic format.
00:04:11
Speaker
And with plans for 2026 already underway, I wanted to know what everyone would be focusing on next year too. So what do I think is the biggest regulatory challenge of 2026, you know, will be? I think there's two and it's more a fork in the road is with the cloud-based regulatory spaces like DNA Nexus and Accumulus, will they start becoming the norm? Because that's such ah ah a game changer.
00:04:37
Speaker
And I think, you know, from an AI standpoint, it's going to be the realization, what's the practical reality versus hype, where people can make, you know, a lot more detailed plans, do better long-range planning. So
Data Quality and Governance Amid IDMP Changes
00:04:50
Speaker
I think those are going to be the the crossroads of next year.
00:04:54
Speaker
And I think that the biggest regulatory challenge of 2026 will be to have the data quality for the regulatory activities ah in shape. So best data quality and also data governance for sure.
00:05:11
Speaker
And I think our biggest regulatory challenge for 2016 is all the IDMP changes. ah We are a company, we have 60,000 markets ah authorization in our system. And with IDMP, we have to move and shift a lot of data from product level to package level. And this is super complex for us.
00:05:36
Speaker
And in terms of the biggest regulatory challenge of 2026, I think the increasing focus on data, data standards and data readiness is where we will need to spend the most of our time with growing IDMP and SPOR requirements and internally the the reliance of on data for new use cases and things like AI.
00:05:59
Speaker
So
Data Readiness and ECTD Momentum
00:06:00
Speaker
I can see that being a lot of work.
00:06:14
Speaker
Here's what stands out for me from 2025 and looking forward to 2026. First of all, it's about making data work for us. IDMP has pushed teams to formalize ownership, tighten governance and measure data quality.
00:06:28
Speaker
The priority though, it has to be around making master data reliable, not just compliant. And that means not just implementing IDMP as a regulatory requirement, though, of course we've all been working towards that, but really using it as an opportunity to build value for life sciences companies.
00:06:45
Speaker
Then there's ECTD momentum. More agencies have moved towards first implementations for ECTD, but each has followed its own timeline and those have definitely evolved throughout the year.
ECTD 4.0 Implementation Deadlines
00:06:57
Speaker
You've absolutely got to keep your eye on the ball to avoid falling behind and complying with these evolving agency requirements.
00:07:04
Speaker
And although nobody's mentioned it, we're not just thinking about ECTD 3.2 implementation. Those ECTD 4.0 implementation dates are on the horizon for next year and Japan's going to be making it mandatory in April.
AI's Tactical Role in Regulatory Life Cycle
00:07:17
Speaker
I think that just highlights how each market really has its own clock when it comes to ECTD and the challenges of being ready for everyone. Last but definitely not least, practical AI. AI was such a hot topic at the user meeting this year. I think it came up with every client I spoke to.
00:07:35
Speaker
We heard about some great uses where the wins were tactical and measurable. Those pilots with clear outcomes and clear goals really produced some fantastic results. We've put together a few resources to help in the show notes.
00:07:51
Speaker
One of my favorite parts of this job is seeing innovations that change how teams work and ultimately how patients are served.
AI in Pharma and Data Management Innovations
00:07:58
Speaker
So for my final question, i wanted to focus on that. What innovations have our guests seen this year?
00:08:06
Speaker
So what's the most innovative thing you've seen in pharma this year? For me, that's that's a hard question because there's so much change going on. And I think it's more about the future in a Genic AI, especially in the medical writing and probably in the discovery area, because right now 3% make it all the way through from discovery to the market. If that goes up to 10%, it's such a game changer for the entire industry and for patients worldwide.
00:08:34
Speaker
And the most innovative thing I've seen in pharma this year is the use of artificial intelligence in different ah procedures and also for making easy the documentation creation and also the data extraction from documents.
00:08:52
Speaker
So what's the most innovative thing you've seen in pharma this year, it's not only this year, but for me one of the biggest thing or maybe is the biggest thing is EPI.
00:09:03
Speaker
With EPI we are able to completely reduce the leaflets from the packers to print a QR ah code on the packages that the customer scans the QR code, that the customer can choose the language. I think for us as ah as a farmer industry, it's a big advantage that we can reuse our warehousing. We can use packages for the whole world, not only for specific country. ah We can reduce the shortage in the winter for the for some medicines. I think this is the right thing into the right direction.
00:09:41
Speaker
So the most innovative thing that I've seen in pharma, I think, is the explosion and expansion in ai use cases. we We did a survey, an informal survey at one of our FPM meetings, and I was blown away by how much a lot of big pharma are doing and and smaller companies as well. um Lots of gen AI for content generation, loads of folks doing innovative things to manage their internal data, increase the the data quality, respond to health agency questions. um the yeah It just seems to be growing exponentially and I'm very excited about what their future brings.
00:10:23
Speaker
Those are some incredible digital initiatives. I said AI was the topic on everyone's mind. And I think Tim just echoes that with his experience talking to fellow FPM members, as well as Steve and Vanessa's and what they're saying.
00:10:36
Speaker
I've been hearing about Gen AI helping with everything from drug discovery to document creation, you know, really spanning the entire regulatory life cycle.
Electronic Product Information Benefits
00:10:45
Speaker
And then we mustn't just think about AI when we talk about digital transformation.
00:10:50
Speaker
Like Stefan, I've had my eye on electronic product information, and I think it really does offer an incredible opportunity to reshape packaging to be both more efficient and more patient centric, whether that's just by offering patients the chance to read a leaflet in their own language or by reducing the risk of shortages.
00:11:09
Speaker
I'll be fascinated
Resources for ECTD, IDMP, and AI Use Cases
00:11:10
Speaker
to see how that evolves over the next few years. If you're building your roadmap, we're here to help. In our show notes, you'll find links to some of my top resources from this year. ECTD 4.0 and IDMP timelines to make sure you're ready for those deadlines. A roundup of some incredible AI use cases we're seeing in action with our clients and our guide to getting IDMP ready and the tools that you'll need to make compliance easy.
00:11:35
Speaker
Thank you
Closing Remarks and Future Invitations
00:11:36
Speaker
so much for joining me from Paris. The Inove user meeting is about practical progress and that came through in every conversation. If you're a customer, we hope to see you at the next user meeting in Denver, Colorado in April, 2026.
00:11:51
Speaker
And if you've got a hot topic you think we should cover next, or you want to join us as a guest, we would love to hear from you. Email newsletter at inove.com. I'll see you on the next episode of the an Innovation Podcast in 2026.