SBIA Education Events

Supporting Events from FDA CDER Small Business & Industry Assistance


FDA REdI Annual Conference 2021

Regulatory Education for Industry (REdI) Annual Conference
July 19 – 23, 2021

View Start Date on World Clock

This conference is FREE

Via Webcast

Featuring three medical product center tracks:

Drugs, Devices, and Biologics

Learn directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics. This course is designed to provide participants with a strong, basic foundation in the FDA’s regulatory requirements.

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Keynote Speaker (July 19):

Dr. Janet Woodcock

Janet Woodcock, MD
Acting Commissioner of Food and Drugs
Food and Drug Administration

Plenary (July 19):

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.

Plenary Speakers:

Dr. Patricia Cavazzoni Dr. Jeff Shuren Dr. Peter Marks
Patrizia Cavazzoni, MD
Director
Center for Drug Evaluation and Research
(CDER)
Jeff Shuren, MD, JD
Director
Center for Devices and Radiological Health
(CDRH)
Peter Marks, MD, PhD
Director
Center for Biologics Evaluation and Research
(CBER)

Topics By Conference Track:

The Drugs Track (July 19-20) will focus on the operations of Center for Drug Evaluation and Research (CDER) offices directly involved in the drug assessment process and their interaction with each other. Topics include

  • CDER NextGen Portal
  • Communication Best Practices
  • Drug Development and Precision Medicine

The Devices Track (July 21-22) will focus on evidence quality and data expectations that impact regulatory decisions involving medical devices regulated by the Center for Devices and Radiological Health (CDRH). Topics include:

  • Premarket submissions
  • Quality system principles
  • Additive manufacturing

The Biologics Track (July 22-23) will focus on the development of advanced therapies, including cellular and tissue-based products, gene therapies, plasma-derived therapeutics, and devices regulated by Center for Biologics Evaluation and Research (CBER). Different aspects of product development will be discussed (product quality, pharmacology toxicology, and clinical). Topics include:

  • “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

View the Full Agenda

Agenda & Speaker Bios

PDF Download
Event Agenda

The Agenda above may be updated if any changes are made. The current version is Version 6, updated on June 14, 2021

PDF Download
Speaker Biographies

The speaker biographies document is being finalized and will be posted here as soon as it is ready.

Join the Live Webcast

The virtual conference will be hosted via Adobe Connect and is limited to 2,000 simultaneous attendees. If a room is full when you attempt to enter, please try the other room.

The links below to the Adobe Connect rooms will be activated about 15 minutes before each day begins.

Join Now: Last Name A – K

Join Now: Last Name L – Z

If you encounter any technical issues, visit the Technical Issues Support Page

The audio for the event will be provided through your computer speakers via Adobe Connect (there will NOT be a teleconference number to dial into). We recommend that you test your PC or mobile device prior to the event and you join the event a few minutes early to address any issues.

To test your PC, please visit:

https://concerted.adobeconnect.com/common/help/en/support/meeting_test.htm

Files, Certificate & Recordings

The three ZIP files above will be available for download ~24 hours before the event.

Link to Final Evaluation & Certificate of Attendance

The above link will become active at the conclusion of the event.

Session Recordings:

Links to recordings will be added here as they become available.

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Questions & More Information

Continuing Education Credit

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 Workshop:

  • has been pre-approved by RAPS as eligible for a maximum of 12 credits per 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.

Questions?

Please refer the FAQs page on this website. If you are not able to find your answer there, please email us at info@sbiaevents.com.

More Information

If you have questions regarding the content of the event or other CDER-specific information, please: