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Resources

Building a shared knowledge base is a core priority. Here, you will find:
• Regulatory frameworks for Managed Access
• Standards, guidance, and best practice documents
• Publicly available industry and academic publications
• Training and educational materials

Some resources may be publicly available, while others may be restricted to members only.

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US Expanded Access Regulations

  • FDA Expanded Access pathways (individual patient and group programs)

  • Roles and responsibilities of sponsors, physicians, and regulators

  • Key regulatory and ethical considerations 

Details
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EMA Regulations

  • EMA Compassionate Use programs

  • National implementation across EU/EEA Member States

  • Interaction between compassionate use, early access, and reimbursement systems

Details
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