People in Pharmacovigilance know ICH GCP (International conference on harmonization-good clinical practices) guidelines are like a religious book for each one of them. However not everyone and every time it is possible to recall them or have time to recollect its complexities. So let’s take a "together we learn" approach. While I may not be an expert, I thought of learning while sharing through this blog.
My first guideline articles I was reading were ICH-E2B (R3) dated 26 Nov 2014 of its working group questions and answers article and Pharmacovigilance planning guidelines too, the pointers I thought important that you might as well find interesting to know, and useful in day to day PV activity are shared below. First thing I noticed that ICH database does not accept values such as < and > in its format. They recommend using standard website for providing standard units and values,…
