The Life Science Rundown

The Life Science Rundown

The Life Science Rundown is a podcast for life science professionals hosted by The FDA Group. We dive deep into topics across the RA/QA/Clinical space, covering news, exploring trends, and picking the brains of expert guests.

Latest Episode

Breaking Down FDA’s E21 Draft Guidance: Including Pregnant and Breastfeeding Women in Clinical Trials with Regina Atim (30.09.2025)

Previous Episodes

  • Staying Ready for the FDA (When Inspections Are Less Predictable) 19.09.2025
  • Building the Next-Gen Lab: AI in a GLP Environment with Catherine Lunardi 19.09.2025
  • How to Build High-Performing Quality Teams with Marcus Gesner 08.09.2025
  • The 4 Cs of MedTech Leadership with Sean Gallimore 19.08.2025
  • The Power (and Pitfalls) of Real-World Evidence with Dr. Manfred Stapff 28.07.2025
  • Quality Is Not a Cost Center—It’s a Culture (with Dr. Kimberly Garko) 16.07.2025
  • From Cost Center to Value Driver: Rethinking Quality in the Life Sciences with Marcia Baroni 08.07.2025
  • Managing Royalties in Biotech, Pharma, and Medtech with David Marlin 10.06.2025
  • GMP Compliance in 503B Compounding Pharmacies with Jesse Gillikan 20.05.2025
  • A Smarter Approach to Supplier Quality Audits with Thermo Fisher's David Festa 28.02.2025
  • Mastering FDA and EMA Regulatory Meetings with Ashley Preston 10.02.2025
  • Working with Chinese CROs: Benefits, Risks, and Best Practices with Harri Järveläinen 05.02.2025
  • The Smart Way to Adopt AI in Clinical Trials and Regulatory Affairs with Keith Parent 22.11.2024
  • Demystifying AI in Life Sciences Supply Chain with Jennifer Chew 15.11.2024
  • Streamlining Promotional Reviews in the Life Sciences with Annalise Ludtke 25.10.2024
  • Navigating Supplier Audits in Japan with Derek Wessman 17.10.2024
  • Small Lots, Big Risks: Rethinking Statistical Sampling in Biopharma 29.08.2024
  • Quality Metrics that Matter with Kimberly Wallbank 19.08.2024
  • Applying AI in the Life Sciences with MasterControl's Matt Lowe 15.07.2024
  • Navigating Challenges in Raw Material and Finished Product Storage with Eric Busenburg 03.07.2024

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