EMAUD course MODULE 4

Objectives
  • Achieve P&R, HTA recommendations, and Formulary inclusion at optimal prices/restrictions
Activities
  • Final Pricing Strategy
  • Launch
    • Negotiation guide
    • Core Value Dossier
    • Adaptation Core Value Dossier to Local Needs
    • Strategic advice
  • Negotiation Skills and Strategy
  • Life Cycle
    • Price database; Coordination sequence; Price Erosion
    • HEOR/Epidemiology
      • Launch
        • FDA/EMEA PRO submission dossier
        • Publication HEOR evidence (Cost-effectiveness, comparative effectiveness, clinical relevance, Phase III HEOR results)
        • Standard HTA dossier
        • Local Adaptation (Cost-effectiveness and local HTA Dossier)
        • HE studies
        • Post-hoc analyses
        • Publications
      • Life Cycle
        • IITs; real life effectiveness
        • Scientific Lobbying
        • Anticipate re-evaluation and update HTA dossier
        • Monitor New entrants/Environment
  • Interaction Affiliates Region and corporate functions for successful market access
Workshop & Case study
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