This conference was intended to provide basic instruction in the registration and listing policy and process for those who are new to this regulatory program as well as offer regulatory professionals more in-depth information on issues and current events affecting Drug Registration and Listing.

Timestamps

00:04 – Keynote

15:20 – How to Submit an Establishment Registration

30:42 – Using the Appropriate Business Operation(s) and Business Qualifier(s)

35:10 – Establishment Registration Renewal, Updates, and De-Registration

47:13 – U.S. Agents and Official Contacts

54:08 – CDER Direct Labeler Code Request Demo

01:08:23 – Who Will Be Assigned a Labeler Code and Who Won’t

01:14:37 – Labeler Code Inactivation and Reactivation

01:24:42 – Updates, Mergers, and Acquisitions

Speakers:

Jill Furman, JD
Director
Office of Compliance (OC)
Center for Drug Evaluation and Research (CDER) | FDA

Regie Samuel
Technical Information Specialist
Drug Registration and Listing Branch (DRLB)
Division of Labeling, Registration and Unapproved Drugs (DLRUD)
Office of Unapproved Drugs and Labeling Compliance (OUDLC)
OC | CDER | FDA

Jose Cabrera
Information Technology Specialist
DRLB | DLRUD | OUDLC | OC | CDER | FDA

Soo Jin Park
LCDR, USPHS
Regulatory Officer
DRLB | DLRUD | OUDLC | OC | CDER | FDA

Laurie Simonds, GWCPM
Technical Information Specialist
DRLB | DLRUD | OUDLC | OC | CDER | FDA

Lalnunpuii Huber
Technical Information Specialist
DRLB | DLRUD | OUDLC | OC | CDER | FDA

Learn more at: [ Ссылка ]

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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.

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