2026-03-22 2026-03-22 , online online, 1,590 € zzgl. MwSt. Marketing Authorisation Documents in the EU

This seminar provides an in-depth exploration of the marketing authorisation dossier and the electronic submission process, focusing on the CTD structure and Modules 1-5. Participants will gain practical knowledge and strategies for successful drug approval applications in the EU.

Themen

Module 1 and 2 of the marketing authorisation dossier
The SmPC and package leaflet
Chemistry, manufacturing and controls (CMC) - Module 3
Compilation of non-clinical and clinical data in Modules 4 and 5
eCTD and electronic submission requirements

Who should attend

This seminar is ideal for professionals involved in the drug approval process needing in-depth knowledge of marketing authorisation documents and submission. Basic knowledge of European marketing authorisation procedures is recommended.

Ziel der Veranstaltung

This seminar aims to provide participants with a comprehensive understanding of the marketing authorisation dossier and its components.

By focusing on the Common Technical Document (CTD) structure and the electronic submission process, participants will gain essential insights into compiling and submitting drug approval documents in the EU.

The seminar also addresses common errors and authority findings to ensure successful applications.

Teilnehmerkreis

Detailed knowledge of the CTD structure and specifications for Modules 1-5
Key elements and structure of the SmPC and package leaflet
Practical insights into compiling non-clinical and clinical data
An understanding of eCTD principles, document requirements and submission
Strategies to avoid common errors and align with authority expectations