Source Documents, Data Privacy and Data Migration
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 […]
Whenever we talk about harmonization of Pharmacovigilance regulations for medicinal products, the first thing that comes to our minds is ICH, which is the International Council of Harmonization. Similarly, for medical devices, we have the IMDRF or the International Medical Device Regulators Forum The Global Harmonization Task Force (GHTF) was founded in 1993 by the […]
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 […]
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… […]