| FDA | Small Business and Industry Assistance CONFERENCES | | Regulatory Education for Industry (REdI) Annual Conference July 19-23, 2021 | | | Join us and learn directly from the FDA's Senior leadership and regulatory experts. This is the FIRST year that our conference includes three medical product tracks: Drugs, Devices, and Biologics This conference is approved for 30.25 units of continuing education for pharmacists, physicians and nurses. Please see detailed announcement for more information.  Keynote Janet Woodcock M.D.
Acting Commissioner of Food and Drugs
Food and Drug Administration | | |  Patrizia Cavazzoni M.D.
Director
Center for Drug Evaluation and Research (CDER) | | Jeff Shuren M.D., J.D.
Director
Center for Devices and Radiological Health (CDRH) |  Peter Marks M.D., Ph.D.
Director
Center for Biologics Evaluation and Research (CBER) | | Tracks Drugs - CDER NextGen Portal
- Communication Best Practices
- Drug Development and Precision Medicine
Devices - Premarket submissions
- Quality system principles
- Additive manufacturing
Biologics - "Tissue Rule": Regulation of products under 21 CFR part 1271
- Development and regulation of cellular therapies, gene therapies, and plasma-derived therapeutics
- Expedited development programs for advanced therapies
| Plenary This plenary session will reflect on FDA's use of Emergency Use Authorizations (EUAs) and other resources in making drug, device, and biological products available to support the public health response to the COVID-19 pandemic.
| | CONTINUING EDUCATION Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event. This course: | | | The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry. | | | |
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