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November 2019

Qdossier presenting at the Topra Autumn Introductory course 2019

5 November 2019 @ 08:00 - 8 November 2019 @ 16:00

The Topra Annual Autumn Introductory course is a comprehensive 4-day introduction to EU Pharmaceutical Regulatory Affairs. Hans van Bruggen (Qdossier) will be presenting on various topics. Common Technical Document Module 1: Administrative Information & Prescribing Information Introduction to CTD Overview of Module 1 Type of application (including abridged applications) Summary of Product Characteristics (SmPC) Application form including appendices PIL user testing EU regional requirements e-Submissions Regulatory guidance leading to eCTD Prerequisites for proper eCTD usage Other e-submission initiatives including PIM…

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