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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
  • EVMPD and IDMP

More information about the course and the program

Details

Start:
5 November 2019 @ 08:00
End:
8 November 2019 @ 16:00