Division of Clinical Research

Office of the Vice President and Innovation

August 25-28, 2020

This workshop is free of cost. Register here.

Interact with and learn directly from FDA’s regulatory experts in drugs and medical devices. This course is designed to provide participants with a strong, basic foundation in understanding the FDA’s drug and medical device regulatory requirements. Presentations include Q&A sessions.

Please select the track of your interest: drugs or devices. The drugs track will be held on August 25th and 26th. The devices track will be held on August 27th and 28th.

  • Drugs Track: This year’s agenda will complete our series of the regulatory timeline which we started in REdI 2018 We will focus on “Post Approval Considerations” as we address the regulatory aspects of selected topics and utilize case studies to exemplify best practices within those areas.
  • Devices Track: A core theme of this program is to consider the role of risk, and risk-benefit into regulatory decisions to help advance the development of safe and effective medical devices.  This program also uses examples and specific case studies to provide a hands-on experience to reinforce the regulatory principles described. 

Continuing Education: Real-time attendance is required for the certificate of attendance. Certificates are only available during the three weeks post-event.

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