Regulatory Education for Industry (REdI)
Annual Conference
June 5-9, 2023
View Day One Start Time on World Clock
This is a NO COST conference
Via Webcast
Featuring three medical product center sessions:
Drugs (CDER), Devices (CDRH), and Biologics (CBER)
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, and also create awareness of current activities.
REGISTER NOW
Visit the SBIA Webpage for Additional Information
The agenda is still being refined and may be updated over time. The current version is v6, uploaded on June 3, 2023.
The speaker biographies document provides detailed information for each of the Conference presenters.
Room One
Ability to submit questions, but cannot pause or rewind
1,000 seats – Use Room Two if this room is full
Room Two
Ability to pause or rewind, but cannot submit questions, download slides below
Unlimited Seating
The above rooms will open ~15 minutes before the webinar begins.
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
Download Presentation Slides:
Evaluations & Certificates:
Evaluation & Certificate of Attendance for CDER Sessions
The above link will only be active until June 23
Evaluation & Certificate of Attendance for CDRH Sessions
The above link will only be active until June 23
Evaluation & Certificate of Attendance for CBER Sessions
The above link will only be active until June 23
Recordings:
- Recording of Livestream from Day One (Keynote, Plenary & Drugs)
- Recording of Livestream from Day Two (Drugs)
- Recording of Livestream from Day Three (Devices)
- Recording of Livestream from Day Four (Devices and Biologics) (coming soon)
- Recording of Livestream from Day Five (Biologics) (coming soon)
Continuing Education Credit
NOTE: Registration and real-time attendance via Adobe Connect are required for continuing education (CE) for physicians, pharmacists and nurses. Real-time attendance is required for the certificate of attendance which can be used in support of CEs for RAPS, SOCRA, ACRP, and SQA.
This Conference has been approved by:
- For up to 32.25 continuing education credits for physicians, nurses, and pharmacists.
- 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.
- 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.
- 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.
- 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:
- Visit the CDER SBIA website
- Learn more about CDER SBIA Workshops and Webinars
- Subscribe to the CDER SBIA email updates
- Follow us on LinkedIn