IT issues during pharmacovigilance audits and inspections
“Some things are inevitable during pharmacovigilance audits and inspections; that doesn’t prevent you from preparing!” In today’s world of information technology (IT) advancement, everyone is talking about artificial intelligence, robotics, automation, and machine learning. It is rather unlikely that things would go wrong during an audit or inspection, more so specifically due to a trivial […]
In the complex world of Pharmacovigilance, maintaining compliance isn’t just about monitoring safety data—it’s about monitoring the monitors. Since becoming a mandatory requirement in 2012 (following 2010 EU legislation), the Pharmacovigilance Audit Universe has become the backbone of quality assurance in drug safety. But what exactly constitutes this “universe,” and how do you effectively manage […]
The pharmacovigilance audit universe is not limited to the distributors, business partners, affiliates,and vendors / service providers. One also needs to consider pharmacovigilance processes as well as processes of cross-functional departments which may have a direct or indirect impact on patient safety compliance. These processes are not limited to: Information Technology (including Safety database) Of […]
It is at the discretion of an inspector to request documents before, during, and after an inspection. A document request after an inspection may call for a surprise even if the closing meeting was uneventful. On-site Vs Remote For obvious reasons, remote inspections are expected to have more document requests before the inspection as compared […]
In the current era, the pharmaceutical industry is witnessing a surge in Mergers and Acquisitions (M&A). As a result, the concept of due diligence has gained significant importance. While there are similarities between audits and due diligence—specifically regarding the review of systems—their fundamental purposes are distinct. Understanding these differences is crucial for Pharmacovigilance professionals navigating […]
The Pharmacovigilance System Master File (PSMF) stands as a crucial document in the realm of Good Pharmacovigilance Practice (GVP). It has been a cornerstone of the guidelines put forth by the European Medicines Agency back in 2012. Regular ad-hoc reviews of the PSMF are a common practice, particularly during audits or due diligence processes. It […]
A robot for handling calls When we think of medical information, the first thing that comes to mind is a call centre representative working in the 9-5 shift and providing information regarding a particular medicine. Imagine if this activity is performed by a robot that is available 24/7/365 and can understand every language and access […]
By safety labels, we refer to the cartons, packaging materials, prescribing information, reference safety information or even the patient information leaflet or consumer information guide, which may contain relevant safety information. The associated safety text gets updated whenever there is any update to the safety profile of the product. The prescribers, pharmacists, nurses, care-givers, or […]
By distributor, we mean the business partners who support the commercialization of the company products in the concerned territories. We won’t discuss the non-compliance areas but provide considerations for the marketing authorization holder (MAH) for ensuring compliance. Every MAH can’t have commercial operations in every country in which it holds licenses. This may even apply […]
The European Medicines Agency introduced the concept of PSMf, and it became effective in July 2012. Until then, the marketing authorization holders (MAH) maintained a detailed description of the Pharmacovigilance system (DDPS). However, the requirement was restricted to human medicinal products (HMP). For veterinary medicinal products (VMP), the requirement continued to be the maintenance of […]