Automation opportunities in Medical Information
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 […]
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 […]
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 […]
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 […]