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.
Steve's top resources:
* Do you have a business case for AI? Answer a few questions to find out [https://en.ennov.com/platform/artificial-intelligence/#assess]
* Know what to ask vendors: Download the AI Vendor Checklist [https://en.ennov.com/insider/guide-ai-vendor-checklist/]
* Simplify agency correspondence with AI: Watch AI in action [https://en.ennov.com/insider/managing-agency-correspondence-with-ai/]
15 Apr 2026
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 [https://en.ennov.com/blog/quality-blog/change-control-regulatory-affairs-connected-systems/]
* See real impact on regulatory productivity: Explore the Septodont case study [https://en.ennov.com/insider/regulatory/case-study-septodont/]
* Break down silos across teams and systems: Learn how to align quality and regulatory [https://en.ennov.com/insider/regulatory/white-paper-unified-quality-rim/]
5 Feb 2026
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 [https://en.ennov.com/blog/regulatory-blog/ectd-4-0-timeline/]
* Know what's changing and why it matters: Read the readiness guide [https://en.ennov.com/blog/regulatory-blog/ectd-4-0-whats-changing-and-how-to-be-ready/%C2%A0]
* Get everything in one place: Visit the eCTD 4.0 resource hub [https://en.ennov.com/ectd-content-hub/]
3 Dec 2025
Perspectives from Paris: What's on the Horizon for 2026
Host interviews four regulatory leaders at the Ennov Europe User Meeting in Paris about their priorities, challenges, and innovation to help listeners plan for 2026.
1 Oct 2025
PMS: Mind the (Data) Gap
Michiel Stam, regulatory lead at MAIN5, discusses the critical steps for preparing for the European Medicines Agency's PMS data enrichment deadlines in this interview.
5 Sept 2025
Combo Products, Complex Rules: Regulatory Strategies for Combination Products
Host interviews Plamena Entcheva-Dimitrov, PhD, RAC, founder of Preferred Regulatory Consulting, about navigating the complex regulatory landscape of combination products.
23 Jun 2025
Beyond Silos: Unifying Quality & Regulatory
Pharmaceutical consultant Paul Palmer and Associate Technical Solution Director David Kalb examine how regulatory and quality departments can collaborate more effectively and discuss upcoming regulatory updates for 2025 in this interview.
28 Apr 2025
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 questions: what does AI really mean for regulatory affairs? And is IDMP finally ready for launch?
Our Top Resources:
> What to look for in an AI vendor. Download the AI Vendor Checklist [https://en.ennov.com/insider/guide-ai-vendor-checklist/]
> See what AI can actually do. Explore use cases in Life Sciences [https://en.ennov.com/platform/artificial-intelligence/#use-cases]
> Simplify agency correspondence. Watch the webinar to see AI in action [https://en.ennov.com/insider/managing-agency-correspondence-with-ai/]
> Know what's coming next. View our updated EMA Timeline [https://en.ennov.com/blog/regulatory-blog/portfolio-ready-data-enrichment/]
> Current RIM not IDMP-ready? See how Ennov EASI can help [https://en.ennov.com/solutions/regulatory/idmp-easi/]
> Preparing for IDMP enrichment? Download the IDMP Starter Pack [https://en.ennov.com/insider/regulatory/idmp-starter-pack/]
13 Feb 2025
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 MHRA consultation on Medical Devices.
* Know what's coming, when. Check out our eCTD 4.0 implementation timeline [https://en.ennov.com/blog/regulatory-blog/ectd-4-0-timeline/]
* Be part of the future of publishing. Download Diarmuid's pilot readiness checklist [https://en.ennov.com/insider/regulatory/ectd-4-0-pilot-readiness-checklist/]
* Get prepared. Catch up on the MHRA's proposals [https://en.ennov.com/blog/mhra-medical-devices-in-vitro-diagnostics/]
* Is your RIM system built for Medical Devices? Navigate MDR/IVDR and UDI with ease with Ennov RIM [https://en.ennov.com/insider/regulatory/compliance-without-compromise-med-device/]
Who has been a guest on Ennovation Podcast
Names identified in recent episode analyses. Showing up to five guests.
regulatory leaders
Michiel Stam
Plamena Entcheva-Dimitrov PhD RAC
Paul Palmer
David Kalb
Reach and audience
Public platform figures. Ratings count people who left a rating, not total listeners.
Spotify
5.0 / 5
7 ratings
Podcast Authority Score: 13 / 100
A composite of feed quality, social presence, YouTube performance and engagement. Read the methodology.
Quality
13
Social presence
0
YouTube
0
Engagement
32
Host of Ennovation Podcast?
Claim your podcast to manage its listing and keep your show details accurate.
Pod Engine is an independent podcast discovery and analytics service and is not affiliated with or endorsed by this podcast. Artwork and show content belong to their owners. Full legal notice.
Explore this show Podcast research with Pod Engine
