This course is designed to promote professionalism in the clinical trial industry for individuals involved with submissions to FDA (Investigational New Drug (IND) application, New Drug Application (NDA), Biologics License Application (BLA)), and to familiarize stakeholders with the regulatory and scientific issues involved in the development and approval of medical drugs and biological products.
The agenda is still being refined and may be updated over time. The current version is v3, uploaded on October 13, 2023.
The speaker biographies document provides detailed information for each of the presenters.
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More Information
If you have questions regarding the content of the event or other CDER-specific information, please: