Ennovation Podcast

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 f...

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 real impact on regulatory productivity: Explore the Septodont case study Break down silos across teams a...

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 what’s changing and why it matters: Read the readiness guide Get everything in one place: Visit the eCT...

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...

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 enrichment deadlines. Michiel’s top resources: Take the first step to readiness. Download the IDMP St...

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 products are more than the sum of their parts. From pre-filled syringes to gene therapies delivered...

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 Director here at Ennov. Together, we explore two timely questions: how can Regulatory and Quality work bet...

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...

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 implementati...