Ennovation Podcast

Episodes

1. 9

   AI in Regulatory: Agents, Answers, Action!

   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 Steve Gens, founder of Gens and Associates, to talk about where AI is really heading in regulatory, beyond the hype cycle....

   Jun 1, 2026

   28 min
2. 8

   The Challenge of Change Management

   Preeya Beczek, a regulatory affairs and compliance expert, joins us to discuss the practical challenges of change management and explore what it takes to implement it effectively. Preeya’s Top Resources: Rethink change control across connected systems: Read the connected change control blog See...

   Apr 15, 2026

   37 min
3. 7

   eCTD 4.0 Pilots: Cleared for Takeoff!

   Diarmuid Waide, Regulatory Product Specialist here at Ennov, gives us a behind-the-scenes look at the EMA’s eCTD 4.0 pilot and what it revealed about the gap between theory and real-world readiness. Our Top Resources Track key implementation deadlines: Explore the updated eCTD 4.0 timeline Know...

   Feb 5, 2026

   20 min
4. 6

   Perspectives from Paris: What's on the Horizon for 2026

   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...

   Dec 3, 2025

   12 min
5. 5

   PMS: Mind the (Data) Gap

   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...

   Oct 1, 2025

   30 min
6. 4

   Combo Products, Complex Rules: Regulatory Strategies for Combination Products

   Welcome back to the Ennovation Podcast, where we bring you the latest trends, insights, and expertise in Life Sciences and Regulatory Affairs. This time, I’m joined by Plamena Entcheva-Dimitrov, PhD, RAC, founder of Preferred Regulatory Consulting. Combination Products Demystified Combination...

   Sep 5, 2025

   19 min
7. 3

   Beyond Silos: Unifying Quality & Regulatory

   Welcome back to the Ennovation Podcast, where we bring you the latest trends, insights, and expertise in life sciences and regulatory affairs. This time, I’m joined by Paul Palmer, pharmaceutical consultant and Director at Pharma Quality Services, and David Kalb, Associate Technical Solution...

   Jun 23, 2025

   14 min
8. 2

   AI Reality Check & The IDMP Countdown

   Welcome back to the Ennovation Podcast, where we bring you the latest trends, insights, and expertise in life sciences and regulatory affairs. This time, I’m joined by Pierre Stanislawski, our IDMP expert, and Josh Keliher, who’s leading the charge on AI at Ennov. Together, we dive into two major...

   Apr 28, 2025

   32 min
9. 1

   eCTD 4.0 & Medical Devices: What's Happening in 2025?

   Welcome to the Ennovation Podcast, where we bring you the latest trends, insights and expertise in life sciences and regulatory affairs. For the first episode, I’m joined by Diarmuid Waide, regulatory expert, and Sean Carpenter, Product Manager. We discuss the latest eCTD 4.0 news and a recent…

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   Feb 13, 2025

   16 min