Hardware Podcasts

108 - Clinical Interpretation, Non-Clinical and Clinical CTD Modules 4 & 5, Pre-IND/IND and Dossiers with Margaret Jenkins

Let's Combinate · 1 Nov 2023 · 38m

What this episode covers

Margaret Jenkins, Founder of Global Pharma Solutions, explains the structure and content of eCTD Modules 4 (Non-Clinical) and 5 (Clinical) for drug-device combination products. She details the progression from pre-IND meetings to Phase 1-3 trials, emphasizing how non-clinical safety data informs clinical dosing and how Module 2 provides expert overviews for regulators. Jenkins also contrasts the US FDA IND process with Australia's faster TGA notification system and discusses post-approval maintenance of the living dossier.

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established companies

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Global Pharma Solutions, FDA, TGA, EMA, Flexel

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