Regulatory Science for BME Certificate Part 2: Fundamentals and Perspectives in Medical Product Regulation for Biomedical Engineers Workshop

Participation in both the virtual webinar and the in-person workshop at the BMES 2025 Annual Meeting will fulfill the requirements for completing a BMES certificate of participation program on the fundamentals of medical product regulation. The certificate program is designed for industry professionals who want to expand their knowledge of regulatory science.

The goal of the webinar is to provide motivation to learn more about regulatory science and to understand the context for the modern regulatory framework. The webinar will cover a brief history of medical product regulation in the US, fundamental laws that enable modern medical product regulation, and regulatory philosophies. It will include the FDA’s risk-based approach to regulatory burden, the shift away from reactive to proactive regulation, and the balance of minimizing public health risk with fostering innovation.

The workshop at the Annual Meeting will impart the fundamentals of translation and regulation of drugs, biologics, and devices in the US, as well as regulatory perspectives from experts in academia and industry.

All participants must register for the BMES 2025 Annual Meeting and purchase a $25 workshop ticket which provides access to both the virtual webinar and the in-person workshop.

If you already registered for the Annual Meeting, you can modify your registration from your registration confirmation and add a ticket for the Regulatory Science for BME Certificate.