
Ennovation Podcast
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Podcast Overview
<p>Welcome to the Ennovation Podcast, where we bring you the latest trends, insights and expertise in life sciences and regulatory affairs.</p>
Language
🇺🇲
Publishing Since
2/13/2025
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Recent Episodes

June 1, 2026
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. 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/]

April 15, 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/]

February 5, 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/]
9 total episodes available
Recent guests on Ennovation Podcast
Guests from recent episodes — sign up to see every guest that has ever appeared on this show.
regulatory leaders
Guest
Michiel Stam
Guest
Plamena Entcheva-Dimitrov PhD RAC
Guest
Paul Palmer
Guest
David Kalb
Guest
Deep-dive analytics for Ennovation Podcast
Frequently asked questions
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- What is Ennovation Podcast?
<p>Welcome to the Ennovation Podcast, where we bring you the latest trends, insights and expertise in life sciences and regulatory affairs.</p> - How often does this podcast release new episodes?
This podcast updates daily.
- Where can I listen to this podcast?
This podcast is available on 4 platforms including Apple Podcasts, Spotify, and more. You can also use the RSS feed directly.
- Does this podcast accept guests?
Information about guest appearances is not available.
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