Business Partner Audits in Pharmacovigilance
The Pharmacovigilance Audit of a business partner can be tricky, as there may be direct or indirect commercial implications associated with the audit’s outcome. A business partner can be a distributor, wholesaler, or even a service provider. For the scope of this article, we will primarily focus on product distributors. There can be more than […]
Many Pharmacovigilance and Quality personnel have approached me in the last few years, requesting a Pharmacovigilance Audit Checklist. I also used to be happy to share the version I had prepared in 2012 for my first audit assignment in the European Union. Some of the requestors reverted, stating that the checklist served the purpose, and […]
Use of blockchain can revolutionize Pharmacovigilance, for ensuring safe medicines for public health.
All these years, Artificial Intelligence or AI was regarded as the future of Pharmacovigilance. Unexpectedly, COVID-19 has accelerated this to such an extent that one can safely say that the future is already ‘present’. The regulatory agencies have already started collaborating with the IT companies for augmenting AI for the large scale COVID-19 vaccine […]
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 […]
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: Medical Information […]
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 […]