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Focus: Regional policy, HTA alignment, regulatory mechanics, and European market readiness.
What are the early takeaways from the initial JCA experiences, and what operational bottlenecks are HTA bodies currently facing?
How will unified European clinical assessments practically translate into national pricing, reimbursement, and economic decisions?
Where can Member States realistically harmonize their processes, and where will national differences remain?
How can the JCA framework be optimized to create a more predictable landscape for developers while accelerating equitable patient access across Europe
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How are recent policy developments influencing pricing dynamics and launch sequencing?
Are companies becoming more selective in where and when they launch, and how does this differ for rare & specialty products vs mass-market therapies?
How do you manage pricing risk across interconnected markets without compromising long-term value?