pv
PV – Is it only Pharmacovigilance?
Having been in the drug safety industry for over a decade, I still have the apprehension to use ‘PV’ and prefer to use the abbreviation ‘PHV’ to denote Pharmacovigilance. Notably, there is some history to it. Until I joined medical school, I never had the opportunity to use the abbreviation ‘PV’. In the first year, […]
FDA Pharmacovigilance Inspections – PADE
“The best way to survive an FDA inspection is to be prepared for it!” An FDA Pharmacovigilance inspection is generally unannounced. However, if it pertains to a foreign/ Non-US site, it is likely to be a pre-announced one. What are the types of FDA Pharmacovigilance inspections? 1. Post Marketing Adverse Drug Experience (PADE) 2. Risk […]