Managing document requests during an Inspection
It is at the discretion of an inspector to request documents prior to, 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 prior to the inspection […]
In the present era, we are witnessing quite a lot of mergers and acquisitions (M&A) in the pharma industry. As a result, the concept of due diligence is gaining a lot of importance. Although there is some similarity between audits and due diligence with regards to the review of the systems, the purpose is different! […]
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 about 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 […]
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 […]
Pharmacovigilance is generally regarded as a cost centre in a pharmaceutical company, and the management will always be on the lookout for further reducing the costs without compromising compliance. One way to achieve this is through automation. There is a galore of automation opportunities available in patient safety. This can be simple automation or by […]
“Human Adverse Reaction” means a noxious and unintended reaction that occurs in a human being following exposure to veterinary medicine. Xylazine (also known as ‘Tranq’) is a powerful sedative that the US FDA has approved for veterinary use. Xylazine is used for sedation, anaesthesia, muscle relaxation, and analgesia in horses, cattle, and other non-human mammals. […]
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 […]