Monthly Archives: May 2020

Kinapse welcomes you to ICH Q12 Back to Kinapse blog May 2020 The USFDA has recently released a presentation and recording of “ICH Q12: Overview and application to Generic drugs” as a part of a 2 day virtual webinar [...]

Back to Kinapse blog March 2020 On 4th March 2020, EMA published adoption of ICH Q12 guideline along with an implementation note which clearly states that the tools and concepts in the ICH Q12 guideline that are not foreseen in the EU [...]