pharmacovigilance
The ‘lot many’ months of COVID-19 lockdown, has allowed some people to answer these ‘simple’ questions: “What is it that gets you up every morning and keeps you going?” or “what is my personal legend?” and thankfully I am one of those fortunate ones who has found an answer to these simple questions! I still […]
Ghana joined the WHO International Drug Monitoring Program in November 2001 as the 65th member of the program and the first country from West Africa to get enrolled. Ever since the Pharmacovigilance guidelines have well evolved. These guidelines are even updated from time to time. The MAH is required to report domestic serious reports within […]
The COVID-19 situation made it possible for regulatory agencies globally to explore all the four facets of unlicensed medicines, namely: 1. Emergency Use Authorization 2. Compassionate Use 3. Named Patient Basis 4. Expanded Access Program The first and foremost thing to understand is that the medicine in question can fall into any of the following […]
“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 […]
Whenever we think about Pharmacovigilance in France, two things come to mind. First is the French Imputability Method of Causality, and the second is ‘Exploitant.’ The concept of ‘Exploitant’ is specific to France. Under the French legal framework, a Marketing Authorization Holder (MAH) which wants to market a medicinal product in France, needs to hold […]
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 […]