Date:
August 25 - 28, 2020
Time:
9:15 AM - 3:20 PM ET

 

About This Event

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.

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. 

This event is a collaboration between the Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance (SBIA) and the Center for Devices and Radiological Health (CDRH) Division of Industry and Consumer Education (DICE).

TOPICS

Who should attend?

  • Regulatory affairs professionals
  • Development and preparation of submissions
  • Newcomers, managers, or directors in the drug or medical device industries
  • Research and development
  • Quality assurance and control
  • Medical device stakeholders who want to find online resources that explain premarket and postmarket regulatory framework for medical devices
  • Regulatory affairs professionals seeking to submit new or novel medical device regulatory submissions, including premarket notifications (510(k)s) and De Novos.
  • Manufacturers and researchers who are responsible for ensuring the cybersecurity of their medical devices.
  • Manufacturers and regulary affairs professionals seeking to enhance their knowledge about the FDA Quality System (21 CFR 820) and applicable subsystems
  • Global manufacturers who are seeking to harmonize their manufacturing activities to comply with multiple country regulatory bodies.

Resources

CDER

CDRH