CDER SBIA | Electronic Drug Registration and Listing Using CDER Direct - October 22, 2019

Electronic Drug Registration and Listing Using CDER Direct

October 22, 2019 | This CDER SBIA event is FREE. 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. Register Now In-person or Online

Topics Include 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 U.S. agents for foreign registrants Importers and import agents Consultants and law firms representing pharmaceutical companies