Ennovation Podcast
Ennovation Podcast
Podcast Description
Welcome to the Ennovation Podcast, where we bring you the latest trends, insights and expertise in life sciences and regulatory affairs.
Podcast Insights
Content Themes
The podcast covers essential topics in life sciences including regulatory changes, compliance updates, and technological advancements, with episodes like 'eCTD 4.0 & Medical Devices' examining upcoming regulations and implementations vital for industry stakeholders.
Welcome to the Ennovation Podcast, where we bring you the latest trends, insights and expertise in life sciences and regulatory affairs.
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 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
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