Regulatory Education for Industry (REdI) Annual Conference
May 29-30, 2024
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This is a NO COST event
The Hotel at the University of Maryland – College Park, Maryland
or attend Virtually Online
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.
Click Here for Workshop Details
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The agenda is still being refined and may be updated over time. The current version is v3, uploaded on April 27, 2024.
Speaker Biographies
The speaker biographies document is under development and will be linked here when it is ready.
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Venue
The Hotel at the University of Maryland
7777 Baltimore Avenue, College Park, Maryland 20740
Phone: 301-277-7777
** Book Your Room Before Wednesday, May 8, 2024 **
BOOK YOUR ROOM
Hotel Information
Book your room before Wednesday, May 8, 2024 to avail of the $159 discounted rate. After this date, the rate or availability will not be guaranteed. You may reserve your guest room by calling THE HOTEL’s reservations line at 301-277-7777 and ask to be included in the “REdI Annual Conference 2024” room block, or make an online reservation at thehotelumd.com. You will be responsible to reserve and pay for your own room accommodations. Please be mindful of the hotel’s policy regarding cancellations and early checkout.
Transportation & Parking
Discounted daily self-parking for attendees: $10.00 (day guests); $14 overnight. Please view the hotel’s Transportation page for transportation and parking information.
Dining
Please view the hotel’s Dining page for information on the food choice in the hotel. Potomac Pizza and Bagel ‘n Grinds allow you to pre-order online, which may help expedite your lunch break.
Networking Opportunity
A networking opportunity is available for on-site attendees during the conference. The networking event will be held in the Lobby Bar at the hotel. This is an optional self-pay event.
Recording Disclosure
This event will be recorded and made available to the public after its conclusion. Any information shared publicly by participants during the event will become part of that recording. This includes the verbal questions and answers sessions.
For Reasonable Accommodations
If special accommodations at the workshop are needed due to a disability, please email CDERSBIA@fda.hhs.gov at least 7 days in advance of the workshop date. Requests for sign language interpretation or Computer Aided Realtime Translation (CART)/captioning should be made 2 weeks in advance of the workshop and should be sent directly to the FDA Interpreting Services Staff email account: interpreting.services@oc.fda.gov.
The evening before the event, links will be added here to log into the event.
If you encounter any technical issues, visit the Technical Issues Support Page
The audio for the event will be provided through your computer speakers (there will NOT be a teleconference number to dial into).
Download Presentation Slides:
ZIP of the CDER Session Slides
ZIP of the CDRH Session Slides
ZIP of the CBER Session Slides
The links above will become active on the day before the event begins.
Evaluation & Certificate:
Evaluation & Certificate of Attendance
The above link will become active near the close of the first day of the event.
Session Recordings:
Recordings will be linked here as soon as they are available.
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 (until June 13, 2024).
This event has been pre-approved for:
- 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.
- 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