Have you heard about the WHOPVResources?
Many times, we come across Pharma companies that want to set up a Pharmacovigilance system but are clueless about how they should start. A similar situation may even be faced by some countries, which are not yet a part of the WHO Programme for International Drug Monitoring. The WHO PV Resources is a collection of […]
Apart from Pharmacovigilance department, there are various allied departments that get reviewed during the inspection. The success of the Pharmacovigilance inspection is largely dependent on how the cross-functional stakeholders have fared. That would also mean that the Pharmacovigilance department needs to ensure that these stakeholders perform their work properly. Pharmacovigilance Department (Primary) Secondary: How about […]
I know this looks like a very basic topic and may not interest everyone working in the field of Pharmacovigilance. However, please note that numerous companies in developing countries (including the highly populated ones) may not have any Pharmacovigilance department. One of the main reasons why these companies hesitate to create one is because setting […]
It is not feasible for pharmaceutical companies to have subsidiaries, affiliates, vendors, or even employees in every country they operate or hold licenses. One that it may not be cost-effective, or the local requirements (regulations/ business policies) may make it difficult to manage them. At times, it may be necessary to have business arrangements even […]
Whenever we think about expedited reporting of adverse event reports, the first number that comes to our mind is 15. This is mainly because ‘most’ of the regulatory agencies require serious reports to be submitted within 15 Calendar Days, and non-serious reports within 90 Calendar Days. The term ‘most’ is the appropriate term as there […]
In the past, Inspections/ audits were synonymous with ‘travel’- both domestic and International, but it is not the norm these days. In 2020, when the Covid-19 crisis plagued the Pharmaceutical industry, many companies had to compromise on their annual audit plans and schedules. With the BCP measures in place, many companies were able to realize […]
Just Imagine! What if we had one set of Pharmacovigilance Guideline(s) for all the SAARC (South Asian Association for Regional Cooperation) Countries! Whenever we think of regional or harmonized Pharmacovigilance, the first thing that comes to our mind is the ‘European Medicines Agency,’ where we have a standard set of Pharmacovigilance Guidelines (GVP) for over […]
Pharmacovigilance requirements are constantly evolving and one may not find it difficult to monitor the requirements in EU, US, Canada, Australia, Japan, India, New Zealand, Singapore, Switzerland etc., as these are available in English and we know where to find them. However, we still need to periodically monitor if anything has changed, as any delay […]
Having been in the drug safety industry for over a decade, I still have the apprehension to use ‘PV’ and prefer to use the abbreviation ‘PHV’ to denote Pharmacovigilance. Notably, there is some history to it. Until I joined medical school, I never had the opportunity to use the abbreviation ‘PV’. In the first year, […]
At a time when the world is transitioning from the mandatory HCP (healthcare professional) reporting, we have a fantastic pilot initiative from the FDA, for empowering consumer/patient reporting. Project Patient Voice is an online platform for patients and caregivers, along with their healthcare providers to look at patient-reported symptom data collected from cancer clinical trials. […]
