# 082 - CTD Structure for Combination Products, US vs. EU Submissions and Regulatory R&R with Niedre Heckman

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2023-04-26
- Length: 43m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-26-082-ctd-structure-for-combination-products-us-vs-eu-submissions-and-regulatory-r
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/082---CTD-Structure-for-Combination-Products--US-vs--EU-Submissions-and-Regulatory-RR-with-Niedre-Heckman-e22t60i

## Summary

Niedre Heckman, Director of Regulatory Affairs Strategy at Takeda, explains the Common Technical Document (CTD) structure for combination products, detailing the five modules and the specific placement of device information in Module 3.2R versus drug manufacturing in 3.2P. She contrasts US and EU submission expectations, noting the EU's more prescriptive guidance on where device data belongs, and describes how regulatory organizations structure their teams around CMC, publishing, and policy. The discussion covers the lifecycle of submissions, including rolling submissions, human factors data placement in Module 5, and the use of Drug Master Files (DMFs) as references.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-26-082-ctd-structure-for-combination-products-us-vs-eu-submissions-and-regulatory-r#t=0) Introduction: Niedre Heckman and the CTD Structure
- [2:19](https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-26-082-ctd-structure-for-combination-products-us-vs-eu-submissions-and-regulatory-r#t=139) Reg CMC Focus and Module 3 Details
- [10:34](https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-26-082-ctd-structure-for-combination-products-us-vs-eu-submissions-and-regulatory-r#t=634) Regulatory Organization Structure and Specialization
- [21:34](https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-26-082-ctd-structure-for-combination-products-us-vs-eu-submissions-and-regulatory-r#t=1294) Combination Product Types: Co-packaged vs. Cross-labeled
- [30:27](https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-26-082-ctd-structure-for-combination-products-us-vs-eu-submissions-and-regulatory-r#t=1827) Human Factors and Clinical Data Placement
- [36:22](https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-26-082-ctd-structure-for-combination-products-us-vs-eu-submissions-and-regulatory-r#t=2182) Rolling Submissions and US vs. EU Differences

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)
- [Intellectual property](https://hardwarepodcasts.com/topic/intellectual-property)

## Most relevant to

large enterprises

## Mentioned

- Takeda (company)
- CTD (other)
- FDA (other)
- EMA (other)
- ICH (other)
- DMF (other)

## Related episodes from other shows

- [#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)
- [#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)
- [#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)
- [#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)
- [Challenges for Regulatory Submission: EU vs. US](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-05-06-challenges-for-regulatory-submission-eu-vs-us) (Global Medical Device Podcast)

## Citing this page

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