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Agenda

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ABOUT THIS CONFERENCE (Hosted by CDER SBIA)

This annual event will provide:

• A demonstration on how-to submit establishment registration and drug listing data using CDER Direct.
• An overview on registration and listing regulatory requirements and compliance framework.
• Case studies for an interactive learning experience at the end of the day.

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

• Explaining the proposed rule on the National Drug Code (NDC) format.
• Providing accurate registration and listing data to avoid submission errors, deficiency letters, manual overrides, and more.
• Discussing drug amount reporting requirements.

LEARNING OBJECTIVES

• Explain who must register and list.
• Provide an overview to FDA’s registration and listing compliance program.
• Describe the formats and segments of the National Drug Code (NDC).
• Discuss OTC drug listing requirements and its relation to OTC Monograph Drug User Fee Program (OMUFA) assessment.

FDA RESOURCES

CONTINUING EDUCATION

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.

TECHNICAL INFORMATION

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• Please contact info@sbiaevents.com for all technical questions.
• If you encounter any technical issues before or during the event, please visit the Technical Issues Support
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