Where the FDA Regulations End and ICH GCP Begins The Differences & Similarities Between the Two Paul Below, CCRA GCP Trainer Medical Research Management, Inc. SoCRA 16 th Annual Conference Adams Mark Hotel, Denver, CO September 29, 2007
This presentation was inspired by Norman Goldfarb, Managing Director of First Clinical Research.
At the 2006 SoCRA Annual Meeting, he asked the question during a session on monitoring, “How many in the audience know at least three differences between the FDA regulations and the ICH GCP Guidelines?”
ICH requires the retention of “essential documents” for at least two years after the approval of a marketing application in an ICH region or until there is no pending or contemplated applications in an ICH region or development is formally discontinued.
ICH compliance generally requires a longer retention time than FDA regulations.