Archives: Speakers

I am a seasoned regulatory affairs expert with nearly ten years of industry experience in medical devices, combination products and in vitro diagnostic devices. My latest experience includes regulatory registration for digital health technologies (DHTs) being utilized in decentralized clinical trials and DHTs being part of the combination product. I have master’s degrees in Biochemistry and Regulatory Affairs and a bachelor’s degree in biotechnology. I have extensive experience in global registrations including FDA, Health Canada, EMA, JMHW, NMPA, and other foreign agencies for various types of medical devices.