Preparation of Conversion of CP/MRP/DCP Electronic Dossiers to UK Marketing Authorisations after Brexit

December 10, 2019 10:00–11:00 Eastern Time (US & Canada)

Based on practical experiences from a test submission and authority feedback, the available regulatory guidance for converting existing eCTD dossiers for European procedures (CP, MRP/DCP) into national UK licenses will be presented and discussed, including the content of the data submission package for Initiating Sequences, the different technical options, and the potential submission strategies.

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