Working After 1.64 Guide

Working "after" or in accordance with 1.64 and its associated sections in R3 requires a shift toward and risk-based management .

: The update aims to make trial processes more efficient. For workers, this often translates to streamlined documentation and a focus on "quality by design" rather than just checking boxes. Working after 1.64

: Following 1.64 ensures that the work performed at a local site is recognized and accepted by regulatory authorities worldwide, such as the US FDA or EMA. Working "after" or in accordance with 1