Note that a repeat conference will NOT be offered this Fall.
The Food and Drug Administration's (FDA’s )
Center for Drug Evaluation and Research Small Business and Industry Assistance (CDER SBIA),
–––– and ––––
Center for Devices and Radiological Health (CDRH) Division of Industry and Consumer Education (DICE) are pleased to announce a co-sponsored event developed just for you.
This Event is FREE! You can REGISTER to attend in person or virtually
This 2-day conference has been pre-approved by RAPS as eligible for up to 12 credits towards
participant's RAC recertification upon full completion.
(Attendance Certificates are only available for TWO WEEKS after the event)
The Regulatory Education for Industry (REdI) Conference is an FDA-led forum that brings together the regulatory educators from FDA’s CDER and CDRH.
The goal of this conference is to provide direct, relevant, and helpful information on the key aspects of drug and device regulations. Our primary audience is that of small manufacturers of drug and/or device medical products who want to learn about how FDA approaches the regulation of drugs and devices.
Because the regulatory principles of drugs and devices are both similar and different, the REdI Conference features a cross-cutting plenary addressing issues which impact both drugs and devices, as well as individual break-out sessions which focus on the unique issues and regulatory requirements of drugs and devices.
Steven E. Porter, Jr. | Commander, United States Public Health Service
Director, Los Angeles District | Office of Regulatory Affairs (ORA) | FDA
Conference Topics include:
- Plenary: Role of Human Factors Engineering in Medical Products Regulatory Reviews and Research
- Device and Drug Inspections
- CDER: Nonclinical Assessment for Small Molecules and Biologic Drug Development; FDA Regulatory Requirements for Clinical Investigators; Communication Pathways
- CDRH: Digital Health; Design Controls; 510(k) Program
All on-site sessions on May 15 & 16, 20178 will take place in the Regency Ballroom located in the Hyatt Regency San Francisco Airport, 1333 Old Bayshore Hwy, Burlingame, CA 94010, USA.
We have a block of rooms at a discounted rate, that will be available on a first-come, first-served basis until April 23, 2018 or until the block is filled. You will be responsible to pay for your own accommodations. Please be mindful of the hotel’s policies on check-in/check-out and cancellation.
Click Here to Book Your Rooms Now
Advance registration is required.
When you register, you may choose to attend either on-site at the Hyatt Regency San Francisco Airport, Burlingame, CA or virtually online via Adobe Connect. We ask that you please honor your registration commitment to help us plan this conference efficiently. If you need to change your registration commitment, please email us at cancelation@SBIAevents.com.
May 15 & 16: Take advantage of the lunch breaks (self-pay events) to network with your colleagues. Reservations are not necessary, simply purchase a lunch and join attendees for casual networking and socializing in the hotel’s lounge.
May 15: Optional, self-pay networking event with colleagues after the conference adjourns. This is a great opportunity to network and socialize with other attendees. This event is also optional for FDA staff. This networking event will be held in the hotel’s 3Sixty Bistro which is located in the Atrium level.