May 29 - May 30, 2019
About This Event
CDER and CDRH invite you to interact with and learn directly from FDA’s regulatory experts.
This course is designed to provide participants with a strong, basic foundation in understanding the FDA’s drug and medical device regulatory requirements. Attendees will leave with a set of tools to assist in preparing regulatory filings and interacting with the FDA. FDA speakers will be available to answer questions one-on-one at the end of each day.
- The drugs track will focus on the essentials of New Drug Applications (NDAs) and Biologics License Applications (BLAs).
- The devices track will address globalization, harmonization, and standardization of medical device regulation.
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