FDA Small Business Regulatory Education for Industry (REdI) Conference September 2016
Presentation Slides and Recordings AGENDA
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 is a LIVE event and will be webcast and recorded. This Event is FREE!
This 2-day conference has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
The Regulatory Education for Industry (REdI) Conference is an FDA-led forum that brings together the regulatory educators from FDA’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (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.
Keynote Speaker - Robert M. Califf, MD, MACC US FDA Commissioner of Food and Drugs
PLENARY: FDA Insights on Products for Rare Diseases and Pediatrics
CDER: Manufacturing Process Validation; Interactions with FDA; Emerging Technology and Inspection of NDA and BLA applications.
CDRH: 510(k); De Novo; Design Controls; and Complaints.
- September 27 & 28: 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.
- September 27: Optional self-pay networking event with colleagues after the conference adjourns. Reservations are not necessary, food and drinks are available for purchase. This is a great opportunity to network and socialize with other attendees. This is event is also optional for FDA staff.
- All networking events will be held in the hotel’s Lobby Lounge.
This forum will be delivered in hybrid format. When you register you will choose to attend either “In-Person Onsite” or “Virtually via Adobe Connect.” You will not be able to make changes after you register, so if you are unable to attend, please email us at cancelation@SBIAevents.com. We ask that you please honor your registration commitment to help us plan and deliver this event efficiently.
Note: Venue is accessible to persons with disabilities. If you have any special accommodation needs, please make requests as soon as possible to info@SBIAevents.com
**NOTE: We have a block of rooms at a discounted rate, that will be available on a first-come, first-served basis until September 12, 2016, or until the block is filled.
Questions: For conference registration questions or logistical questions, contact: info@SBIAevents.com
For more information:
CDER SBIA Workshops and Webinars