Hardware Podcasts

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

Let's Combinate · 9 Nov 2022 · 44m

What this episode covers

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.

Most relevant to

large enterprises

Topics

Mentioned

Companies
Amgen, AbbVie, Abbott, Guidant
Also
FDA, ICH, ISO 14971

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