Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 16

The objectives of this chapter are to:

 Provide an outline of legislation, events, and circumstances which provide the background and history for the development of the ICH GCP Guideline E6 R2.

 Offer thoughts and points of view on why the GCP mindset emerged among the global regions most involved in pharmaceutical drug development occurred.