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

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2023-11-01
- Length: 38m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2023-11-01-108-clinical-interpretation-non-clinical-and-clinical-ctd-modules-4-5-pre-ind-in
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/108---Clinical-Interpretation--Non-Clinical-and-Clinical-CTD-Modules-4--5--Pre-INDIND-and-Dossiers-with-Margaret-Jenkins-e2bajr7

## Summary

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.

## Chapters

- [0:01](https://hardwarepodcasts.com/podcast/lets-combinate/2023-11-01-108-clinical-interpretation-non-clinical-and-clinical-ctd-modules-4-5-pre-ind-in#t=1) Introduction and Margaret Jenkins' Background
- [9:43](https://hardwarepodcasts.com/podcast/lets-combinate/2023-11-01-108-clinical-interpretation-non-clinical-and-clinical-ctd-modules-4-5-pre-ind-in#t=583) eCTD Module Structure: CMC, Non-Clinical, and Clinical
- [11:15](https://hardwarepodcasts.com/podcast/lets-combinate/2023-11-01-108-clinical-interpretation-non-clinical-and-clinical-ctd-modules-4-5-pre-ind-in#t=675) Module 4: Non-Clinical Safety and Mechanism of Action
- [16:14](https://hardwarepodcasts.com/podcast/lets-combinate/2023-11-01-108-clinical-interpretation-non-clinical-and-clinical-ctd-modules-4-5-pre-ind-in#t=974) Module 5: Clinical Efficacy, Safety, and Phase Trials
- [15:59](https://hardwarepodcasts.com/podcast/lets-combinate/2023-11-01-108-clinical-interpretation-non-clinical-and-clinical-ctd-modules-4-5-pre-ind-in#t=959) Module 2: Expert Overviews and Summaries
- [24:20](https://hardwarepodcasts.com/podcast/lets-combinate/2023-11-01-108-clinical-interpretation-non-clinical-and-clinical-ctd-modules-4-5-pre-ind-in#t=1460) Post-Approval Maintenance and Live Dossiers
- [33:31](https://hardwarepodcasts.com/podcast/lets-combinate/2023-11-01-108-clinical-interpretation-non-clinical-and-clinical-ctd-modules-4-5-pre-ind-in#t=2011) US FDA vs. Australian TGA Clinical Trial Processes

## Topics

- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Careers & education](https://hardwarepodcasts.com/topic/engineering-careers-and-education)

## Most relevant to

established companies

## Mentioned

- Global Pharma Solutions (company)
- FDA (company)
- TGA (company)
- EMA (company)
- Flexel (company)

## Related episodes from other shows

- [#342: Planning an FDA Submission](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-11-02-342-planning-an-fda-submission) (Global Medical Device Podcast)
- [#323 The Combination Products Handbook](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-16-323-the-combination-products-handbook) (Global Medical Device Podcast)
- [#380: Navigating the Complex World of Combination Products with Subhi Saadeh](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-08-30-380-navigating-the-complex-world-of-combination-products-with-subhi-saadeh) (Global Medical Device Podcast)
- [Managing Clinical Data Activities](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-07-07-managing-clinical-data-activities) (Global Medical Device Podcast)
- [#467: Combination Product Compliance: PMOA, 21 CFR Part 4 & QMS Alignment](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-08-03-467-combination-product-compliance-pmoa-21-cfr-part-4-qms-alignment) (Global Medical Device Podcast)

## Citing this page

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