Mastering compliance for combination products with Dr. Khaudeja Bano

In this episode of Clinical Data Talks, Sylvain Berthelot welcomes Khaudeja Bano, an industry leader with over 25 years of experience across top pharmaceutical companies and deep expertise in diagnostics, therapeutics, and combination products. Together, they unpack compliance and safety management for combination products and examine how rapid drug-device innovation is moving healthcare directly into patients' hands.

With a distinguished background that includes serving on the working group that helped establish 21 CFR Part 4 regulations, Khaudeja shares how the rise of GLP-1 auto-injectors and drug delivery systems is redefining safety data collection. She explains why pharmaceutical sponsors must take holistic ownership of safety, efficacy, and risk management across the entire product – from evaluating human factors and needle protection to feeding real-world usability data back into next-generation device design.

Sylvain and Khaudeja discuss the nuances of global regulatory frameworks across the US FDA, EMA, and PMDA, why the controlled environment of clinical trials offers an ideal setting to listen to the patient voice, and how bringing technology partners directly to the regulatory table creates smoother compliance workflows.

Tune in to explore how combination products are reshaping safety surveillance, cross-industry collaboration, and the future of patient-centered healthcare.