Welcome back to the Ennovation Podcast, where we bring you the latest trends, insights, and expertise in life sciences and regulatory affairs. If this is your first time tuning in, we usually sit down with one guest for a deep dive into a specific topic. But this time, we’re doing something a little different.
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.
What Leaders Are Focusing on Now
Across all four conversations—Steve Gens, Vanesa Espurz, Stefan Schulenburg, and Tim Powell—three themes came up again and again: IDMP and data readiness, eCTD expansion, and AI that’s practical, measurable, and scalable.
Whether it’s tackling data complexity in IDMP, preparing for eCTD 4.0 rollouts (with Japan going live in April 2026), or piloting AI for real-world use cases, one thing is clear—the pace of change has never been faster. And the systems we use must evolve to keep up.
What Is Coming for 2026
Looking ahead, IDMP and SPOR will get more demanding, as we start to hit deadlines for enrichment. More regulators are launching eCTD, and each one follows its own timeline. And AI? It’s moving out of pilot phase and into production, especially in areas like document generation, data comparison, and regulatory intelligence.
If you’re building your 2026 roadmap, I hope this episode gives you insight into what your peers are thinking.
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
Have a topic you would like us to cover, or want to join us as a guest?
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See What’s Next
Join us at the Ennov User Meeting – Denver, April 27–29, 2026 to connect with peers, preview upcoming innovations, and shape the next version of Ennov.
Don’t miss your chance to be part of the conversation. Register now.