Drugs

Regulatory Education for Industry (REdI): Electronic Drug Registration and Listing Using CDER Direct: October 2, 2018

2018 Electronic Drug Registration and Listing Using CDER Direct

October 2

Location:

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Tommy Douglas Conference Center (TDCC)
(Ballroom C&D, Building 9)
10000 New Hampshire Avenue
Silver Spring, MD 20903

Why Attend?

As the registration renewal and drug listing recertification period approaches, this event will educate and assist drug firms with the registration and listing process.

Experts and helpdesk technicians will be there in-person to answer regulatory and technical questions and assist with submissions.

Who Should Attend?

Those who want to learn more about drug registration and/or listing with CDER Direct.

Session Highlights

FDA will walk-through submissions and discuss the following:

  • Establishment Registration
  • Product Listing
  • Top 10 Errors
  • Compliance Cases
  • Listing Recertification
  • Labeler Code Request
  • National Drug Code Reservation
  • DRLS Compliance Program
  • 503B Product Reporting for Compounding Outsourcing Facilities
FDA Resources
Continuing Education (CE)

This event is eligible for up to six credits towards a RAC recertification.

Only in-person attendance will qualify for the CE. Attendance certificates are only available for two weeks after the event.

Recording Disclosure

FDA intends to record this event and make the recordings available publicly after the event. Information shared publicly by participants during the event will become part of that recording. This includes the verbal questions and answers sessions.

Questions

For questions about this event, e-mail info@sbiaevents.com.

 

 

Page Last Updated: 10/03/2018
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