With so many controversy happening around us regarding ethical issues or scientific issues in clinical trials planned, leading to tightening of guidelines for conducting clinical trials it is imperative for us as well working in PV to have overview of E2A guidelines which talks about PV in clinical trials. After discussing in my last 2 posts about ICHE2B and E2E and some other generic guidelines of IS-International conference on harmonization, I thought of extending more on ICHE2A guidelines. E2A guidelines mostly covers the handling of Pharmacovigilance for clinical studies.
And those who come across know it is imperative to know thoroughly guidelines as clinical trials are taken with utmost seriousness by MAH (Market authorization holder or layman term -pharma company) and HA (health authorities) both. ICH has added a very important point that sums up, why expedited reporting for…
