Module 12 2019

Summary Gateway

• Gateway replaces the burning of a CD/DVD and shipment per courier to EMA (only EMA) o Less costs o Quicker (Especially important for the evaluation and maintenance) • EMA committed to perform the technical validation within 4 hours • Experience with WebClient o New MAA (dossier of 4 GB within 30 minutes)

o Variations (smaller shipments: 1-10 MB). o Technical validation in matter of minutes - New MAA: 40 minutes - Maintenance: 2-5 minutes

The Organisation for Professionals in Regulatory Affairs