# 058 - PMSR Globally, Different Clinical Roles and Risk Management with Khaudeja Bano

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2022-11-09
- Length: 44m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2022-11-09-058-pmsr-globally-different-clinical-roles-and-risk-management-with-khaudeja-ban
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/058---PMSR-Globally--Different-Clinical-Roles-and-Risk-Management-with-Khaudeja-Bano-e1qdp6j

## Summary

Dr. Khaudeja Bano, Vice President of Combination Product Quality at Amgen, discusses the global regulatory landscape for post-market surveillance reporting (PMSR) and the distinct clinical roles within pharmaceutical and medical device companies. She explains how risk management must be integrated into a closed-loop lifecycle, contrasting the condensed timelines of device development with the extended phases of pharmaceutical trials. Bano details the organizational structures of medical affairs, pharmacovigilance, and clinical teams, highlighting the significant variability in global reporting requirements and the ongoing challenges in harmonization across different geographies.

## Chapters

- [0:02](https://hardwarepodcasts.com/podcast/lets-combinate/2022-11-09-058-pmsr-globally-different-clinical-roles-and-risk-management-with-khaudeja-ban#t=2) Introduction: Khaudeja Bano and Amgen
- [2:02](https://hardwarepodcasts.com/podcast/lets-combinate/2022-11-09-058-pmsr-globally-different-clinical-roles-and-risk-management-with-khaudeja-ban#t=122) Patient Centricity and the Shift from Safety to Quality
- [6:37](https://hardwarepodcasts.com/podcast/lets-combinate/2022-11-09-058-pmsr-globally-different-clinical-roles-and-risk-management-with-khaudeja-ban#t=397) Career Transitions and Taking Calculated Risks
- [11:54](https://hardwarepodcasts.com/podcast/lets-combinate/2022-11-09-058-pmsr-globally-different-clinical-roles-and-risk-management-with-khaudeja-ban#t=714) Risk Management and Closed-Loop Feedback
- [15:21](https://hardwarepodcasts.com/podcast/lets-combinate/2022-11-09-058-pmsr-globally-different-clinical-roles-and-risk-management-with-khaudeja-ban#t=921) Medical Affairs and Clinical Roles in Devices
- [25:59](https://hardwarepodcasts.com/podcast/lets-combinate/2022-11-09-058-pmsr-globally-different-clinical-roles-and-risk-management-with-khaudeja-ban#t=1559) Pharmaceutical vs. Device Organizational Structures
- [37:21](https://hardwarepodcasts.com/podcast/lets-combinate/2022-11-09-058-pmsr-globally-different-clinical-roles-and-risk-management-with-khaudeja-ban#t=2241) Global PMSR Reporting Models and Harmonization Challenges

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Scaling production](https://hardwarepodcasts.com/topic/scaling-production)

## Most relevant to

large enterprises

## Mentioned

- Amgen (company)
- AbbVie (company)
- Abbott (company)
- Guidant (company)
- FDA (other)
- ICH (other)
- ISO 14971 (other)

## Related episodes from other shows

- [#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)
- [Inside Look into ISO 14971:2019 & ISO TR 24971:2020 from the Author's Point of View](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-02-10-inside-look-into-iso-14971-2019-iso-tr-24971-2020-from-the-authors-point-of-view) (Global Medical Device Podcast)
- [QMSR: The Future of FDA's Quality Management System Regulation for Medical Devices](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-16-qmsr-the-future-of-fdas-quality-management-system-regulation-for-medical-devices) (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)
- [Developing a Regulatory Strategy](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-11-23-developing-a-regulatory-strategy) (Global Medical Device Podcast)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/lets-combinate/2022-11-09-058-pmsr-globally-different-clinical-roles-and-risk-management-with-khaudeja-ban. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Let's Combinate.