Blog
Five Steps to Inspection Readiness
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...
Can we use GCP / PV audits as an inspection exercise?
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...
Why everyone involved in clinical research should read the revision of ICH E8
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...