Drugs

FDA Small Business Regulatory Education for Industry (REdI): Fall Conference September 27-28, 2017

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Register Heredisclaimer iconThis Event is FREE!AGENDAdisclaimer icon

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
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 - TBD

Conference Topics include:

  • CDER: Types of INDs; Chemistry, Manufacturing and Controls (CMC); Pharmacology/Toxicology; Drug Inspections
  • CDRH: 510(k); Biocompatibility in Premarket Submissions; Nonconforming Product; Device Inspections.

Advance registration is required.
When you register, you may choose to attend either on-site at the Hilton Rockville Hotel 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.

Networking Opportunities.
September 27 & 28: Take advantage of the lunch breaks (self-pay events) to network with your colleagues. 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. This is a great opportunity to network and socialize with other attendees. This event is also optional for FDA staff.

These are optional self-pay events, and reservations are not necessary. Food and drinks will be available for purchase on own. All networking events will be held in the hotel’s Olive’s Bistro.

For more information on
CDER SBIA
(866)-405-5367 | (301)-796-6707 | CDER Small Business and Industry Assistance

CDER SBIA Learn

Page Last Updated: 09/11/2017
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