ICH Q9 (r1) is in step 2, which means it is out for comments.
Section 5, “Risk Management Methodology” is greatly expanded, with a discussion on just what level of formality means in risk management using three criteria of uncertainty, complexity, and importance. Section 5 then goes into risk based decision making to a greater depth than seen previously in guidances.
Section 6 is greatly expanded as well.
I need to read this in more depth before providing a deeper analysis.
Investigations of a Dog 