Blog

Inspectors are knocking on your door! Your organisation knew this was going to happen. It was just a matter of time, since your organization just applied for a new medicinal product marketing authorisation. People are getting anxious. There is so much to do: documents...

Audits are a great opportunity to get used to the way inspectors (like most auditors) look at things, how interviews and document requests should be handled.  But can we really use GCP / PV audits as an inspection exercise? As an auditor, I (still) see audits on a...

In the shadow of the new European Clinical Trial Regulation, which finally entered into application on 31 January 2022, revision 1 (R1) of ICH Guideline E8 on general considerations for clinical studies was adopted by the (global) Regulatory Members of the ICH...