Early Access Program: Toolbox
Expanded Access Program (EAP) toolbox
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Forecast & Planning
Proactive approach to ensure the appropriate policies, procedures, resources, tools and partnerships are established to support expanded access requests and programs.
Execution
Management of a flexible supply chain, while navigating and evolving regulatory environment, to successfully distribute expanded access material to patients.
Closeout
Implementation of a strategy to transition patients from expanded access material to commercial material supply chain.
Additional concepts
Maintenance, benchmarking and development of policies, procedures, relationships and tools to remain current with the ever changing.
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