117 – Post Market Surveillance, Safety Reporting, Databases, Platforms Health Hazards Assessments and Product Responsibilities with Khaudeja Bano

On this episode, I was joined by Khaudeja Bano, VP of Quality for Combination Products at Amgen.

In this episode, the we discuss the details related to post-market safety reporting for combination products. The conversation extends to the comparison connecting safety and quality, the importance of cross-functional teams for risk management, and the approach towards health hazard assessments. Additionally, they delve into managing product responsibilities, the varied international reporting requirements, and the use of technology for improved efficiency.

Timestamps

00:54 Post-Market Safety Reporting
05:23 Challenges in Post-Market Safety Reporting
07:57 Reporting Databases
10:05 21 CFR Part 4b Guidance
11:50 Managing Product Responsibilities
19:12 Challenges in Handling Platforms
23:10 Understanding Health Hazard Assessment
25:32 International Approach to Reporting

Dr. Khaudeja Bano is the VP of Combination Products Quality at Amgen. Executive director of combination product safety. She's held multiple roles at other companies as well like Abbvie, Abbott, and Guidant and is the chair of the Post Market Safety committee for the combination products coalition.