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

00:26 – Recent Automated Validation Rules

15:15 – Case Studies

29:28 – Q&A Discussion Panel

Speakers:

Lalnunpuii Huber
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)
Office of Compliance (OC)
Center for Drug Evaluation and Research (CDER) | FDA

Julian Chun
Pharmacist
DRLB | DLRUD | OUDLC | OC | CDER | FDA

Panelists:

Lalnunpuii Huber, Julian Chun

and

Yajun (Jason) Tu, PharmD, PhD, BCSCP
LCDR, USPHS
Program Management Officer
Policy and Operations Branch (POB)
Division of User Fee Management (DUFM)
Office of Management (OM) | CDER | FDA

David Mazyck
Consumer Safety Officer
DRLB | DLRUD | OUDLC | OC | CDER | FDA

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

Tasneem Hussain
Pharmacist
DRLB | DLRUD | OUDLC | OC | CDER | FDA

Vikas Arora
Pharmacist
DRLB | DLRUD | OUDLC | OC | CDER | FDA

Leyla Rahjou-Esfandiary
Lead Consumer Safety Officer
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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