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. …

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 …

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-…

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 q…

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 a…

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 comin…