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希少な腫瘍領域製品の上市の手引き:米国および欧州で成功するための普遍的な戦略

Navigating the bench to market barriers required to successfully launch a rare oncology product is inherently challenging. Several factors such as limited patient populations, incomplete evidence and accelerated timelines complicate establishing value of these treatments. For global companies planning to launch in the U.S. and Europe, significant differences in regulatory and market access landscapes complicate matters even more.

In this white paper, Certara’s Global Market Access experts highlight the most consequential differences to consider when preparing to launch a rare oncology product in major markets and recommend universal strategies that will improve your chances of success.

Download now: Strategies to ensure rare oncology launch success

What you’ll learn:

  • How early engagement with regulators can shape approvals and reimbursement pathways
  • The importance of maintaining an active dialogue with key stakeholders to strengthen health care provider (HCP) engagement
  • Best practices for use of real-world evidence (RWE) post launch

Authors: Linnea Koller and Rebecca Calvo-Cruz

 

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