gvp

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 […]

The Pharmacovigilance Audit of a business partner can be tricky, as there may be direct or indirect commercial implications associated with the audit’s outcome. A business partner can be a distributor, wholesaler, or service provider. For the scope of this article, we will primarily focus on product distributors. There can be multiple business partners in […]

Liechtenstein is a small country that is located between Austria and Switzerland. Liechtenstein is not a part of the European Union, but it is a part of the European Economic Area (EEA) and the European Free Trade Association (EFTA). Courtesy: Google Maps Switzerland is a part of EFTA, and not a part of EEA. On […]

Health Canada (HC) is one of those authorities which has set its expectations with regards to GVP inspections clearly and there is a lot of information available on the HC website to substantiate this. Did you know that HC has a dedicated website for GVP inspections, where one can find information on the Pharma entities […]