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Key Considerations for a Successful EU Orphan Drug Launch
Launching your drug product onto the European Market can present a real challenge if you are not familiar with country specific requirements. With its 28 member states, numerous official working languages and complex regulatory framework, this webinar will clarify the key requirements for a successful EU product launch.
The speakers in this webinar are experts in navigating market requirements and supporting client partners to successfully launch their orphan drug products into Europe. They have extensive practical experience in the areas of regulatory, quality, packaging design and distribution of launching products into the various EU and ROW markets ensuring launch timelines are met and market entry strategy is successful.
During this interactive webinar, the speakers involved will utilise 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 (Regionalisation, Blue Box, Serialisation)
- Supply Chain considerations for a temperature sensitive product
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