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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.
The agenda is still being refined and may be updated over time. The current version is v6, uploaded on May 12, 2024.
Speaker Biographies
The speaker biographies document is under development and will be linked here when it is ready.
Venue
The Hotel at the University of Maryland
7777 Baltimore Avenue, College Park, Maryland 20740
Phone: 301-277-7777
Hotel Information
You may reserve your guest room by calling THE HOTEL’s reservations line at 301-277-7777 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:
The links above will become active on the day before the event begins.
Evaluation & Certificate:
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:
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: