Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 66

1 To describe in general terms the roles and responsibilities of a regulatory affairs organizational unit and their role in meeting GCP expectations.

2 To reflect on the nature and purpose of interactions with competent authorities and the links that such interactions have to GCP.

3 To outline the important and sometimes challenging aspects of communicating with competent authorities during drug development.

4 To identify key times when meetings with competent authorities play an important role in the communications process about the development scheme.

5 To outline the general scheme of submissions associated with drug development activities and where they intersect with GCP.