Qualified Person for Pharmacovigilance – Emerging Requirements
The concept of Qualified person for Pharmacovigilance in the European Union (EU-QPPV) existed even before the GVP modules became effective in July 2012. However, the position gained importance in the non-EEA countries after the advent of the GVP modules. In the past decade, many regulatory agencies have come up with the requirement of a single […]
The Pharmacovigilance function is required to have a robust Quality Management System (QMS) and for this, one needs to have efficient standard operating procedures or SOPs. Apart from the SOPs, one can consider other documents, such as working practices (work instructions) or guidelines/guidance documents, as recommended in the QMS of the organization. The list of […]
It was July 2012 when the European Medicines Agency made it mandatory for all the marketing authorization holders (MAH) to maintain the Pharmacovigilance System Master File (PSMF) as per the GVP Module II. Until then, the document was a concise one and called as the detailed description of Pharmacovigilance system (DDPS). After the PSMF came […]
Although remote audits and inspections have become a norm after the onset of the COVID-19 pandemic, the limitations of remote auditing remain! There is no doubt that remote audits cannot take precedence over on-site or face-to-face audits. Hence, a middle path is needed, primarily when the whole industry evaluates using Artificial Intelligence (AI), Machine Learning […]
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 service provider. For the scope of this article, we will primarily focus on product distributors. There can be multiple business partners in […]
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 […]
