safety
By safety labels, we refer to the cartons, packaging materials, prescribing information, reference safety information or even the patient information leaflet or consumer information guide, which may contain relevant safety information. The associated safety text gets updated whenever there is any update to the safety profile of the product. The prescribers, pharmacists, nurses, care-givers, or […]
In general, the overall process of product identification to authorization, may take at least 5-10 years. However, in case of pandemics, public health emergencies, or certain other cases, the overall timeline may need to get shortened. One such action, that supports this, is the rolling review. A rolling review is a regulatory tool, that the […]
Medicinal products that are authorised for use in animals are called Veterinary Medical Products (VMP). Medicated feed is a mixture of animal food and veterinary medicinal product produced under controlled conditions. This has the purpose of treating or controlling disease in farmed animals, aquaculture species and pets. By far, medicated feed is the most effective […]
Safety Data Migration can be undertaken using the following methods: 1. Manual Entry and processing: Simplest, cost-effective, and suitable for small datasets (~100 ICSRs). The ICSRs are manually entered into the new system; source documents are attached. 2. Migration from Excel: The ICSR data is extracted from the spreadsheet database and migrated into the safety […]
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 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 […]
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 […]
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 […]