How to Plan and Implement an Expanded Access Program (WS28)

The attendee will be able to:

  1. Identify 3 access considerations and be able to distinguish between considerations that are strategic verses operational.
  2. Know 3 regulatory requirements that influence how an Expanded Access program should be set up.
  3. Identify 3 aspects of a supply plan for an EA study that must be monitored for change.

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