Regulatory Education for Industry (REdI)
June 6-10, 2022
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, and also create awareness of current activities.
Plenary (June 6):
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.
Topics By Conference Track:
The Drugs Track (June 6-7) will focus on several key components of the PDUFA VII goals. It will identify new processes and enhancements to existing practices of the human drug review program, including new approaches to increase efficiencies and expand communication and feedback. Subject matter experts will provide cutting edge insights and perspectives on how these goals will be implemented at the practical level.
The Devices Track (June 8-9) will provide an introduction to the device regulatory framework, and useful insights into the development of a high quality marketing submission. It will also discuss key program updates across the device total product lifecycle to allow audiences to be current on important device regulatory policies.
The Biologics Track (June 9-10) will focus on the development of advanced therapies, including cellular and tissue-based products, gene therapies, and xenotransplantation products. Speakers will present updates on various regulatory aspects of cellular and gene therapy product development along with new topics related to the regulation of xenotransplantation products and post-marketing safety signal evaluation and risk mitigation for approved advanced therapies.
The Agenda will be updated as additional information becomes available. The current version is v5, uploaded on May 28, 2022.
The speaker biographies document is currently under development and will be posted here when it is ready.
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.
Please select the correct room based on the first letter of your LAST NAME.
Select the first room if you require closed captioning.
Download Presentation Slides:
Evaluations & Certificates:
Evaluation & Certificate of Attendance for CDER Track
Evaluation & Certificate of Attendance for CDRH Track
Evaluation & Certificate of Attendance for CBER Track
The above links will become active at the end of each track.
Links to recordings will be added here as they become available.
- 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)
- Recording of Livestream from Day Five (Biologics)
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.
- 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.
If you have questions regarding the content of the event or other CDER-specific information, please: