Distributor / License Partner Non-Compliance
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 […]
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 […]
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 […]
The Pharmacovigilance function is required to have a robust Quality Management System (QMS) and for this, one needs to have efficient standard operating procedures or SOPs. Apart from the SOPs, one can consider other documents, such as working practices (work instructions) or guidelines/guidance documents, as recommended in the QMS of the organization. The list of […]