qppv

Imagine a situation where a relatively unknown country wants you to submit a PSMF within 24 hours, and you achieve this with a click of a button! Doesn’t that sound fascinating? Unfortunately, it is not that easy! Companies find end-to-end PSMF automation a tricky exercise, although it is not impossible. Besides, one must remember that […]

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 […]

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 […]

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 […]

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 […]