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Workshop

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


Date:
October 22, 2019
Time:
09:00 AM - 04:00 PM EDT
Location:
Event Location
The Hotel
at the University of Maryland

7777 Baltimore Ave.
College Park, MD 20740
United States


Digital Location
Attend in-person or online
Registration:
https://sbiaevents.com/edrls2019/
2019 EDRLS graphic 1200x675

 

 

Register Now   Agenda 

This event is FREE and open to the public.
Attend in-person or online.

Bring your laptop and submit your annual registration and listing renewals on the spot.

The drug registration and listing staff is hosting a workshop dedicated to assisting industry with creating complete and accurate registration and listing submissions.

This year will focus on the top errors and mistakes observed with submissions and highlight 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

    Continuing Education Credits

    This course:

    • has been pre-approved by RAPS as eligible for credits towards a participant’s RAC recertification upon full completion.
    • is eligible for SOCRA credit in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area. Candidate must provide documentation of participation.
    • has been pre-approved by SQA as eligible for 0.25 non-GCP or non-GLP units for every 1 hour of instructional time towards a participant’s RQAP re-registration.
    • is approved for ACRP research-specific continuing education at the completion of this activity. Contact hours are provided at 1 point/hour for at least 45-60 minutes of qualified material.

    Technical Information

    The audio for the event will be provided through your computer speakers via Adobe Connect (there will NOT be a teleconference number to dial into). We recommend that you test your PC or mobile device prior to the event and you join the event a few minutes early to address any issues.
    To test your PC, please visit: Adobe Connect Diagnostic Test

    Questions

    Please contact info@sbiaevents.com for all technical questions.

    For Reasonable Accommodations

    If special accommodations at the workshop are needed due to a disability, please email CDERSBIA@fda.hhs.gov at least 7 days in advance of the workshop date. Requests for sign language interpretation or Computer Aided Realtime Translation (CART)/captioning should be made 2 weeks in advance of the workshop and should be sent directly to the FDA Interpreting Services Staff email account: interpreting.services@oc.fda.gov.