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Agenda

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ABOUT THIS EVENT

This conference is 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. FDA 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 focused on 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

• Explaining the latest proposed rule on the National Drug Code (NDC).
• Learning about the current automated validation rules for registration and listing submissions.
• Providing accurate registration and listing data to avoid submission errors, deficiency letters, manual overrides, and more.

LEARNING OBJECTIVES

• Explain who must register and list.
• Provide an overview to FDA’s registration and listing compliance program.
• Explain how the strength conversion is calculated in listing SPLs.
• Describe the formats and segments of the National Drug Code (NDC).

FDA RESOURCES

• Federal Register Revising the National Drug Code Format and Drug Label Barcode Requirements
• Electronic Registration and Listing Instructions
• Electronic Registration and Listing Compliance Program
• Strength Conversion in Drug Listing
• Structured Product Labeling Resources

CONTINUING EDUCATION

This conference has been approved for 6.50 contact hours of continuing education for physicians, pharmacists, and nurses. Please see detailed announcement for more information. After the course concludes, the attendees will receive an email with instructions and a code to claim their credit. Only participants who attend the live broadcast via Adobe Connect will receive the claim code.

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

• To optimize your webinar experience, use Chrome when viewing Adobe Connect in a browser.
• 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
• Test your PC for use with Adobe Connect prior to the day of the event. Adobe, the Adobe logo, Acrobat and Acrobat Connect are either registered trademarks or trademarks of Adobe Systems Incorporated in the United States and/or other countries.