Today, join the Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH), Center for Drug Evaluation and Research (CDER), and Center for Biologics Evaluation and Research (CBER) for the 2021 Regulatory Education for Industry (REdI) Annual Conference. When: - July 19-20: CDER Drugs track
- July 21-22: CDRH Devices track
- July 22-23: CBER Biologics track
Registration is FREE! NOTE: To earn CME, CPE, CNE, RAPS, SOCRA, SQA, ACRP credits, you must register and login to the live Adobe Connect broadcast. or KEYNOTE Janet Woodcock, M.D., Acting Commissioner of the US Food and Drug Administration PLENARY The plenary session will reflect on the 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. | The program topics feature the following: Drug Track (July 19-20) - CDER NextGen Portal
- Communication Best Practices
- Drug Development and Precision Medicine
Device Track (July 21-22) - Premarket submissions
- Quality system principles
- Additive manufacturing
Biologic Track (July 22-23) - "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
Attend virtually. Participants can join us virtually by Adobe Connect. To test your PC, visit: Adobe Connect Diagnostic Test. Continuing Education. This conference has been pre-approved by RAPS, SOCRA, SQA, and ACRP. Credit hour guidelines vary by organization. For more information, please visit the REdI Conference web page. For technical assistance with the webcast, please email at info@sbiaevents.com. |
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