Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 50

In Chapter 1 – History of GCP outlines key aspects of the birth of the ICH organization and its growth from 1990 to the present day. This chapter will not repeat that material but rather will outline how the ICH E6(R2) reflects the harmonized expectations of the industry‐regulatory authority collaboration which began working to draft the GCP Efficacy Guideline almost immediately after the establishment of the ICH as an organization.