Causality Assessment in Veterinary Pharmacovigilance
It is a well-known fact that adverse drug experiences can affect not only human beings, but also the animals, or even the environment. However, it is essential to evaluate the correlation between drug exposure and the adverse event. Causality assessment is a method used for estimating the strength of the relationship between drug(s) exposure and […]
The recent revocation of the Ulipristal licence to indicate uterine fibroids has reminded the Pharmacovigilance community about the importance of Drug-induced liver injury, or DILI. Incidentally, DILI is one of the most typical reasons for product withdrawals. Drug-induced liver injury (DILI) is uncommon but a potentially fatal cause of liver disease associated with medications and […]
Health Canada (HC) is one of those authorities which has set its expectations with regards to GVP inspections clearly and there is a lot of information available on the HC website to substantiate this. Did you know that HC has a dedicated website for GVP inspections, where one can find information on the Pharma entities […]
Nobody can deny the fact that COVID-19 has ensured that companies engaged in Pharmacovigilance activities have a well functioning business contingency plan (BCP) in place to ensure work continuity. Thankfully some of the regulatory agencies declared that they have deferred their inspection plans, although some expressed their intention of conducting remote inspections… […]
The primary objective of Pharmacovigilance is to ensure that safe and effective medicines are available for Public Health. In August 2020, the FDA removed the Boxed Warning about amputation risk from the diabetes medicine canagliflozin, based on the review of new data from three clinical trials. This boxed warning was imposed in May 2017. Thanks […]
