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♦ Regulatory Affairs

Strategic consulting, pricing and market access

  • Start-up foreign companies including corporate, administrative and medical affairs aspects.
  • Strategic advice, finalization and critical evaluation of price negotiating dossiers; prices renegotiation.
  • Strategic advice, finalization and critical evaluation of dossiers for the introduction of new molecules in the Regional Therapeutic Formulary (PTOR) and Local Formulary (PTO).
  • Planning and active participation in price negotiation at the central level.
  • Planning and active participation in the meetings for PTOR and PTO introduction.
  • Finalization and implementation of tools needed to support pharmacoeconomic aspects (e.g. cost analysis, Budget Impact Model, publications, etc.).