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Five Key Steps for Early Managed Access Programmes

Five Key Steps for Early Managed Access Programmes

Managing an Expanded Access Programme can bring many challenges for pharma companies, such as navigating the complex regulatory landscape, logistical planning, ethical concerns and unsolicited requests from increasingly well-informed patients.

Pharma IQ spoke to Gregory Tuyteleers, Global Operations Lead, Managed Access at Janssen, to gain his expert recommendations on "5 Key Steps for Early Managed Access Programmes". In this checklist, Gregory leads us through crucial considerations including:

  • The need for a governance body
  • Adopting a company-wide approach to early access 
  • Compliance with regulations from country to country

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