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Case Study : European Managed Access Program

Issue

Orphan Drug manufacturer has submitted dossiers to the FDA and EMA, the product was a new class and treatment for a rare condition.

They had requests from physicians and patients from across Europe and Globally. The company although established had conducted no Access Programs before and did not have a global regulatory or operational footprint. They wished to assess the options and potentially implement a global program.

Action

Uniphar specialist teams

  • Provided strategic consultancy reviewing all regulatory options in differing countries designing a European and Global Access Program.
  • Implemented a range of country specific programs encompassing
    • Cohort programs – charged and free of charge
    • Named patient programs – charged and free of charge
  • Designed all materials, processes, procedures and Liaised with Country regulatory agencies to submit relevant applications.
  • Provided bespoke registration & data collection systems with a specialist online portal.
  • Provided all logistics operations including storage, dispatch and monies collection.

Outcome

  • Over 1500 patient treatments delivered in compliant programs
  • RWD collected and analysed for HEOR and regulatory submissions
  • Increased experience of product by thought leaders.

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