Webinar | July 22, 2019

Key Considerations For A Successful EU Orphan Drug Launch

Source: Almac Group

During this interactive webinar, the speakers involved will utilize their experience to guide you through the EU product launch process, from submitting your Marketing Application (MA) to final distribution of drug product to the end-user.

By watching you will gain insight into:

  • The European regulatory framework.
  • The importance of the role of a Qualified Person (QP) and European market release requirements.
  • Key European packaging considerations (Regionalization, Blue Box, Serialization).
  • Supply Chain considerations for a temperature sensitive product
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