Submitting FDA Electronic Regulatory Filings - Drug Establishment Registrations and Drug Listings This webinar on FDA electronic filings will discuss and provide clarification on the process of submitting drug establishment registration and drug listing information to the FDA using its Electronic Submission Gateway (ESG).
Why Should You Attend: To facilitate the submission of drug establishment registration and drug listing information (including labeling), FDA adopted the use of Extensible Markup Language (XML) files in the Structured Product Labeling (SPL) format. The necessary submissions to remain compliant include an Establishment Registration SPL, an NDC Labeler Code Request SPL and a Drug Listing SPL. Once the SPL file is created, it can then be submitted (uploaded) to the ESG. This includes digital certification since the submission is a secure one. This webinar will allow participants to gain a better understanding of the electronic submission process for drug establishment registrations and drug listings. During the session, we will discuss key concepts including XML, SPL, and ESG. The training has been designed to be a stepby-step guide in helping you transition to the electronic process. Areas Covered in the Webinar: Overview of FDA drug establishment and listing requirement Transition from paper-based to electronic process Creation of electronic files o Extensible Markup Language (XML) o Structured Product Labeling (SPL) o Codes and code sets Establishing FDA Gateway (ESG) account Submission to ESG Checking drug establishment registration and listing status Who Will Benefit: This webinar will provide valuable assistance to: Pharmaceutical Regulatory Affairs professionals Project Managers Pharmaceutical QA and QC Managers Drug manufacturers including prescription, over-the-counter (OTC), active pharmaceutical ingredient (API), homeopathic, and medical gas Consultants Any individuals interested in the drug industry
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