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Workshop | Mixed

Event Title
Electronic Drug Registration and Listing Using CDER Direct
October 22, 2019


Date:
October 22, 2019
Time:
9:00 AM - 4:00 PM ET
Location:
Event Location
The Hotel
at the University of Maryland

7777 Baltimore Ave.
College Park, MD 20740
United States


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View Slides

Session Speaker
Welcome from CDER’s Office of Compliance Rosemary Cook
Director, Office of Program and Regulatory Operations
Office of Compliance (OC) | CDER
Keynote from the Drug Registration and Listing Staff Paul Loebach
Director
Drug Registration and Listing Staff (DRLS) | CDER
Establishment Registration and Labeler Code Requests Don Duggan
Lead Consumer Safety Officer
Puii Huber
Technical Information Specialist
Drug Registration and Listing Staff (DRLS) | CDER
Panel Discussion Drug Registration and Listing Staff (DRLS) | CDER
NDC Reservation, Drug Listing, Compounded Product Reporting David Mazyck
Consumer Safety Officer
Troy Cu
Technical Information Specialist
Soo Jin Park
Regulatory Officer
Drug Registration and Listing Staff (DRLS) | CDER
Listing Certification and Inactivation Regie Samuel
Technical Information Specialist
Leyla Rahjou Esfandiary
Lead Consumer Safety Officer
Drug Registration and Listing Staff (DRLS) | CDER
Compliance Program and Case Study Tasneem Hussain
Pharmacist
Julian Chun
Pharmacist
Drug Registration and Listing Staff (DRLS) | CDER
DRLS Panel Questions and Discussion DRLS Staff

About

The drug registration and listing staff hosted a workshop dedicated to assisting industry with creating complete and accurate registration and listing submissions. This year focused on the top errors and mistakes observed with submissions and highlighted FDA’s newly announced process for inactivation of uncertified listings.

Topics Covered

  • Drug registration and listing compliance program featuring a case study of a violation
  • Registration and labeler code requests
  • NDC reservation, drug listing, and 503B compounder product reporting
  • Listing certification and FDA inactivation of uncertified listings
  • Town hall with the DRLS staff

Intended Audience

  • Regulatory affairs professionals working on registration and listing or who submit Structured Product Labeling (SPL) to FDA
  • Members of Industry who submit Registration and Listing
  • US Agents for Foreign registrants
  • Importers and import agents
  • Consultants and law firms representing pharmaceutical companies

Keynote FDA Speaker

Paul Loebach, Director
Drug Registration and Listing Staff | Office of Program and Regulatory Operations CDER | FDA

FDA Resources


 
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