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

Let's Combinate - Combining Drugs and Devices

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.

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.