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 all the information regarding the company’s medicinal products; you can ask questions in any language, and you are assured a response in the same language within 30 seconds! This is going to be the future of medical information. In the era of machine learning, yo ..read more

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 even the patients may refer to these labels and hence it is essential these are updated at all times. In some countries there is a concept of Urgent Safety Restrictions, where the marketing authorization ..read more

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 apply to large countries where the MAH has limited operations, e.g., an MAH operating in the US (which has 50 states in all) but having commercial operations in only 25 states. The MAH may consider having a commercial ..read more

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 DDPS until January 2022, when the veterinary good pharmacovigilance practice (vGVP) guidelines became effective. The PSMF for VMP differs from that for HMP (GVP Module 2). One common thing is that we have ..read more

Pharmacovigilance is generally regarded as a cost-center in a pharmaceutical company, and the management will always be on a look-out for further reducing the costs, without compromising compliance. One way to achieve this, is through automation. This can be simple automation, or by use of intelligent automation, which is through Artificial Intelligence (AI) or machine learning (ML). Automation of pharmacovigilance activities is expected to have a significant impact on public health, either direct or indirect. The initial set-up costs may be high, but the return of investment is expected to be ..read more

“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. It is also referred to as the Zombie drug. Fentanyl is a synthetic opioid 50 to 100 times more potent than morphine. It is strictly a prescription product which is primarily used in pain management. Fentanyl may also be illicit ..read more

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 PSMF non-compliance is one of the most common observations during a Pharmacovigilance inspection. Also, PSMF is the first document requested before the Safety Inspection. The agency may provide as little as seven calendar days to submit this bulky document. An e ..read more

Many regulatory agencies require companies to submit aggregate safety reports periodically for their products. Examples of aggregate safety reports include periodic safety update reports (PSURs), periodic benefit-risk evaluation reports (PBRER), Addendum to Clinical Overview (AdCO), Voluntary Malfunction Summary Report (VMSR), Cosmetic Product Safety Report (CPSR), developmental safety update report (DSUR), IND-Annual Report, etc. Many misconceptions exist about aggregate safety reports. These may be related to the type of reports, type of products (device/drug/cosmetic) or the geography to wh ..read more

A pharmaceutical company is any commercial entity that may be associated with research, manufacturing, commercialization or distribution of medicinal products. This entity may or may not own the product license, and this factor may decide if this entity will or will not fall under the purview of pharmacovigilance regulations. That doesn’t prevent the company personnel from getting trained on basic pharmacovigilance requirements. What do the regulations state? The EMA GVP Module 1 states the following: “All personnel involved in the performance of pharmacovigilance activities shall receive init ..read more

Working in the pharmacovigilance department can be a ‘happening one’ or even a roller-coaster ride. This is irrespective of whether you work for a pharmaceutical company, service provider, monitoring centre, or regulatory agency. Dealing with the rigmarole is going to be a rewarding experience and a satisfying one as you ultimately contribute to the welfare of public health. Changing regulations This is very common, although the extent of change is unpredictable. The situation may be complex for multinational pharma companies with operations in multiple countries. An efficient regulatory intel ..read more