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June 9, 2021
Regulatory Education for Industry (REdI)
Annual Conference
July 19-23, 2021
Dear International Colleague,
Interested in receiving a strong, basic foundation on the FDA's regulatory requirements? Then consider joining us for the Regulatory Education for Industry (REdl) Annual Conference. You'll learn directly from the FDA’s Senior leadership and regulatory experts. This is the FIRST year that the conference includes three medical product tracks:
Drugs, Devices, and Biologics
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Keynote
Janet Woodcock M.D.
Acting Commissioner of Food and Drugs
Food and Drug Administration
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Plenary Session Faculty
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Patrizia Cavazzoni, M.D.
Director
Center for Drug Evaluation and Research (CDER)
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Jeff Shuren, J.D., J.D.
Director
Center for Devices and Radiological Health (CDRH)
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Peter Marks, M.D., Ph.D.
Director
Center for Biologics Evaluation and Research (CBER)
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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.
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
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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:
- has been pre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
- has been pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
- has been pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
has been approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.
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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will not reach the CDER SBIA staff. If you have comments or questions, contact us at CDERSBIA@fda.hhs.gov or 1-866-405-5367 or (301) 796-6707.
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