voisin consulting

Expanded Access Programs

Voisin Consulting Life Sciences advises on Expanded Access Programs (EAP), also known as:

  • Early access
  • Compassionate use
  • Autorisation Temporaire d’Utilisation (ATU) in France
  • Law 648/96 in Italy
  • Design and implementation of Expanded Access Programs
  • Preparation of global strategic plans
  • Protocols for therapeutic use (PTU)
  • EAP-specific Summary of Product Characteristics (SmPC)
  • EAP-specific Case Report Forms (CRF)
bsi

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