Expanded Access Trials/ Comp Use (WS5)

Many government agencies have recently created regulations that allow for using non-marketed drugs in life-threatening situations where clinical protocols do not exist.  Commonly known as “compassionate use”, there are a variety of classifications depending on the region across the world.  This workshop will provide a discussion of the various types of scenarios under the Expanded Access umbrella with examples of how to prepare for the increase in demands they will generate.