FDA’s Drug Registration and Listing Workshop: Compliance, Regulatory and Submission Updates

This SBIA workshop will feature updates from the U.S. Food and Drug Administration (FDA) on establishment registration and drug listing submissions, including current validation rules, evolving regulatory requirements, and compliance considerations. Attendees will have the opportunity to learn about recent developments affecting these processes and hear discussions on strategies for addressing drug amount reporting requirements.

The program will also examine FDA’s final rule on Revising the National Drug Code Format and Drug Label Barcode Requirements and its potential impact on future National Drug Code (NDC) formatting. The workshop will conclude with a panel discussion featuring subject matter experts, providing attendees with an opportunity to explore key regulatory changes, discuss implementation considerations, and gain additional insight into current compliance and reporting expectations.

Intended Audience

• Regulatory science and regulatory affairs professionals working on establishment registration and drug listing submissions and data compliance.
• Consultants and vendors assisting industry with Structured Product Labeling (SPL) submissions to FDA.
• Healthcare professionals using drug listing data and downstream databases to access prescribing and labeling information.
• Foreign drug manufacturers and importers that manufacture and import drugs for US commercial distribution.

Topics Covered

• Providing the latest updates for submitting accurate registration and listing data to avoid submission errors, deficiency letters, manual overrides, and more.
• Discussing drug amount reporting requirements and compliance outcomes.
• Explaining the final rule Revising the National Drug Code Format and Drug Label Barcode Requirements and the future format of the NDC.

Continuing Education (CE)

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This course has been pre-approved by:

• RAPS as eligible for a maximum of 12 credits for a two-day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
• SOCRA who accepts documentation of candidate participation 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.
• SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
• ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

Visit the event page for more information.