Ennovation Podcast

Ennov
  • 0.0 (0)
  • Business
  • Updated Bimonthly

Welcome to the Ennovation Podcast, where we bring you the latest trends, insights and expertise in life sciences and regulatory affairs.

Episodes

  1. AI in Regulatory: Agents, Answers, Action!

    6d ago ·  Video

    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 Know what to ask vendors: Download the AI Vendor Checklist Simplify agency correspondence with AI: Watch AI in action

    29 min
  2. The Challenge of Change Management

    Apr 15 ·  Video

    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 real impact on regulatory productivity: Explore the Septodont case study Break down silos across teams and systems: Learn how to align quality and regulatory

    37 min
  3. eCTD 4.0 Pilots: Cleared for Takeoff!

    Feb 5 ·  Video

    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 what’s changing and why it matters: Read the readiness guide Get everything in one place: Visit the eCTD 4.0 resource hub

    20 min
  4. Perspectives from Paris: What's on the Horizon for 2026

    12/03/2025 ·  Video

    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 perspectives, borrow what works, and plan ahead for 2026. Our Top Resources Get ready for eCTD 4.0: View the upcoming deadlines See how AI is being used today: Read the top use cases Set your strategy for 2026: Download the IDMP Starter Pack

    13 min
  5. PMS: Mind the (Data) Gap

    10/01/2025 ·  Video

    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 enrichment deadlines. Michiel’s top resources: Take the first step to readiness. Download the IDMP Starter Pack  Is your portfolio ready for enrichment? Access the downloadable PDF timeline Understand long-term alignment strategy. Watch the PMS Data Alignment webinarBonus:  Want PMS-ready data without overhauling your RIM? Learn about Ennov EASI

    30 min
  6. Combo Products, Complex Rules: Regulatory Strategies for Combination Products

    09/05/2025 ·  Video

    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 DemystifiedCombination products are more than the sum of their parts. From pre-filled syringes to gene therapies delivered via light-activated devices, these innovations span multiple product types as well as complexity levels. These variations and complexities can make a product's Regulatory journey challenging. Plamena walks us through the practical realities of navigating these challenges, with a few tips on how to make the journey a little less bumpy. Our top resources: Understand combination product requirements. Read the global strategy essentials blog Align regulatory and quality from day one. Watch the Med Device RIM & QMS session Pharma-first RIM systems don’t work for devices. Learn about what you need instead

    20 min
  7. Beyond Silos: Unifying Quality & Regulatory

    06/23/2025 ·  Video

    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 Director here at Ennov. Together, we explore two timely questions: how can Regulatory and Quality work better together, and what 2025 regulatory updates should you be paying attention to? Our top resources: > Replace silos with a unified ecosystem: Read the case study > Plan your next system upgrade: See 2025 RIM & QMS best practices > Why unified beats “integrated”: Read the platform comparison blog > Looking to streamline operations? Download the Unified RIM & QMS white paper

    14 min
  8. AI Reality Check & The IDMP Countdown

    04/28/2025 ·  Video

    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 > See what AI can actually do. Explore use cases in Life Sciences > Simplify agency correspondence. Watch the webinar to see AI in action > Know what’s coming next. View our updated EMA Timeline > Current RIM not IDMP-ready? See how Ennov EASI can help > Preparing for IDMP enrichment? Download the IDMP Starter Pack

    33 min
  9. eCTD 4.0 & Medical Devices: What's Happening in 2025?

    02/13/2025 ·  Video

    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 Be part of the future of publishing. Download Diarmuid’s pilot readiness checklist Get prepared. Catch up on the MHRA’s proposals Is your RIM system built for Medical Devices? Navigate MDR/IVDR and UDI with ease with Ennov RIM

    17 min
  • 9 Episodes

About

Welcome to the Ennovation Podcast, where we bring you the latest trends, insights and expertise in life sciences and regulatory affairs.

Information