pharmacovigilance
Let me start off by asking a couple of questions… 1. How do you handle expired medicines at the home, office or in a healthcare set-up? 2. Can Pharmacovigilance affect only human beings and animals)? I recollect many instances where I have, or some near or dear one has discarded old and unused medicines by […]
Not all companies would consider setting up affiliate offices/ subsidiaries in all countries where they wish to operate or commercialize products. The Pharma company may consider nominating a distributor or business partner in such scenarios. Besides, companies may even consider co-marketing arrangements in countries already operating, using own-label or private-label supplies or other means such […]
Gone are the days when companies used to have complete access to all source documents (electronic and non-electronic), following any kind of M&A. One need not get surprised if the migrated data does not have even basic information such as the name of the patient. It is quite logical that one may get concerned if […]
It may be prudent to state that a Pharmacovigilance professional may have experienced or participated in at least one Safety data migration project in his/ her lifetime, directly or indirectly. Scaling up of Pharmacovigilance Systems is generally associated with the up-gradation of the Safety database, infrastructure updates (? change from on-premise to Cloud) or even […]
At a time when the whole world is looking forward to the COVID vaccine, the million-dollar question is obviously how billions of people will get immunized. At the same, time, the billion-dollar question is, how are Pharmacovigilance activities going to be managed if the Vaccine hopes really materialize? In a country like India, where Pharmacovigilance […]
At a time when the world is plagued by the COVID-19 crisis and when there is no approved medicine/ vaccine for managing it, Pharmacovigilance professionals are busy, remotely processing and reporting adverse event reports. In such a situation, it is quite reasonable that one may come across any of the following eleven scenarios: 1. COVID-19 […]
Quite often in Pharmacovigilance department, you would find people who get annoyed upon hearing terms such as deviation, CAPA and change controls. If utilized properly, change control can serve as an effective project management tool. Considering the dynamic nature of the Pharmaceutical business, it is essential that the Pharmacovigilance department does not miss out on […]
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 […]