Early Access Program: Toolbox

Expanded Access Program (EAP) toolbox

The content of this website is provided by GCSG’s Expanded Access Program e-Team (EAP) and is to be used for guidance and planning purposes only. GCSG accepts no liability for the content of this website, or for the consequences of any actions taken on the basis of the information provided, unless that information is subsequently confirmed in writing. The intended recipient of this website is advised to verify the content of this website with your company‚Äôs regulatory representatives or the appropriate regulatory agencies. If you are not the intended recipient, you are notified that disclosing, copying, distributing or taking any action in reliance on the contents of this information is strictly prohibited.

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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