Quality Expectations for Drugs and Biologics during Early Development: Phase 2 (701010LIVE)
|Event Date/Time: Sep 30, 2008|
This presentation will be aimed at helping Regulatory, Quality Assurance and Quality Control personnel to understand the varying levels of quality activities that accompany early stages of Product development.
There are certain quality-related activities that are expected when information is gathered for the CMC section of an application. The nature and extent of these activities depend on the form of the experimental studies during the different phases of clinical trials. This presentation will discuss the quality-related activities that are expected for Phase 2 products used in clinical studies. Emphasis will be placed on the transition into full GMP work as clinical trials proceed, but the requirements for NDAs (or BLAs) will be discussed. The quality elements for CMCs that are needed for Phase 2 clinical studies will be presented.