# 045 - "Combination Products around the Globe" with Susan Neadle

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2022-08-10
- Length: 35m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2022-08-10-045-combination-products-around-the-globe-with-susan-neadle
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/045---Combination-Products-around-the-Globe-with-Susan-Neadle-e1m8ijj

## Summary

Susan Neadle, Principal Consultant at Combination Products Consulting Services LLC and former Head of Combination Products at Amgen, discusses the global regulatory landscape for combination products. She details the status of pending FDA guidances, including Essential Performance Requirements (EPRs) and post-market modifications, and explains the ASTM International standard for harmonizing terminology across jurisdictions. Neadle contrasts regulatory approaches in the US, EU, Canada, China, and other regions, highlighting differences in how products like pre-filled syringes are classified and reviewed.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2022-08-10-045-combination-products-around-the-globe-with-susan-neadle#t=0) Introduction: Susan Neadle and Combination Products Consulting Services
- [1:58](https://hardwarepodcasts.com/podcast/lets-combinate/2022-08-10-045-combination-products-around-the-globe-with-susan-neadle#t=118) CPC Summit Updates and Pending FDA Guidance on EPRs
- [3:28](https://hardwarepodcasts.com/podcast/lets-combinate/2022-08-10-045-combination-products-around-the-globe-with-susan-neadle#t=208) Defining Essential Performance Requirements (EPRs) and Control Strategy
- [6:10](https://hardwarepodcasts.com/podcast/lets-combinate/2022-08-10-045-combination-products-around-the-globe-with-susan-neadle#t=370) Post-Market Modifications and Human Factors Guidance Status
- [8:59](https://hardwarepodcasts.com/podcast/lets-combinate/2022-08-10-045-combination-products-around-the-globe-with-susan-neadle#t=539) ASTM International Terminology Standard and Harmonization Efforts
- [15:27](https://hardwarepodcasts.com/podcast/lets-combinate/2022-08-10-045-combination-products-around-the-globe-with-susan-neadle#t=927) Global Regulatory Differences: US, EU, Canada, and China Classifications
- [22:23](https://hardwarepodcasts.com/podcast/lets-combinate/2022-08-10-045-combination-products-around-the-globe-with-susan-neadle#t=1343) Regional Approaches: UK, Japan, Australia, and Middle East
- [25:47](https://hardwarepodcasts.com/podcast/lets-combinate/2022-08-10-045-combination-products-around-the-globe-with-susan-neadle#t=1547) Upcoming ASTM Committees on CGMPs and Risk Management
- [33:44](https://hardwarepodcasts.com/podcast/lets-combinate/2022-08-10-045-combination-products-around-the-globe-with-susan-neadle#t=2024) Upcoming Combination Products Conferences and Industry Outlook

## Topics

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

## Most relevant to

established companies

## Mentioned

- Combination Products Consulting Services LLC (company)
- Amgen (company)
- Johnson & Johnson (company)
- FDA (other)
- ASTM International (other)
- WHO (other)
- Health Canada (other)
- EMA (other)
- TGA (other)
- ISPE (other)

## Related episodes from other shows

- [#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)
- [#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)
- [Developing a Regulatory Strategy](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-11-23-developing-a-regulatory-strategy) (Global Medical Device Podcast)
- [#449: 7 Pitfalls of International MedTech Expansion](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-03-02-449-7-pitfalls-of-international-medtech-expansion) (Global Medical Device Podcast)

## Citing this page

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