SOURCE: Xtalks

Xtalks Webinars

August 11, 2016 07:00 ET

Key Considerations for a Successful EU Orphan Drug Launch, New Webinar Hosted by Xtalks

TORONTO, ON--(Marketwired - August 11, 2016) - During this interactive webinar, experts from Almac will utilize their experience to guide attendees through the EU orphan drug launch process, from submitting Marketing Authorization applications to final distribution of drug product to the end-user. The live broadcast takes place on Thursday, September 8, 2016 at 12pm EDT.

Launching an orphan drug product onto the European market can present a real challenge if the company is 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 markets, ensuring launch timelines are met and market entry strategy is successful.

By participating, attendees 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

To learn more or register for this complimentary event, visit: Key Considerations for a Successful EU Orphan Drug Launch

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

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