In pharmacovigilance, case processing is the fundamental activity that provides data for the analysis of adverse effects that allows to detect new safety concerns and to periodically assess the benefit to risk ratio associated with the use of a pharmaceutical product. The precision and quality of safety data processing, also from the medical point of…

Post-authorization studies (PAS): European & American approach Randomized trials are the gold standard in evaluating the efficacy of new healthcare interventions. However, despite their ability to potentially provide causal estimates of the efficacy of new treatments, their general nature in relation to patients in the real world is often unclear. Strict exclusion criteria may lead…

Digital Transformation and Industry 4.0 – these are the topics regularly featured in titles of Life Sciences events and publications recently. While we talk a lot about technologies that disrupt drug development, clinical trials, and pre-clinical stage processes, it is difficult to come across materials dedicated to the new technologies in pharmacovigilance. A less noticeable…

Pharmacovigilance activities have long been fundamental to companies seeking market approval in both the drug and device development process. For this reason, many companies decide to outsource some of the their tasks in order to improve efficiency in managing their Pharmacovigilance Systems. However, once you know what functions and expertise you want to keep in-house…

Pharmacovigilance Market size is expected to exceed USD 8 billion by 2024; according to a new research report by Global Market Insights, Inc. Growing number of adverse drug reactions (ADRs) coupled with increasing prevalence of chronic diseases will drive global pharmacovigilance market size. Below a snapshot from today to 2024: To download our infographic, click here. Continue…

Starting on the 22nd of November 2017, new improvements and changes will affect users of the EudraVigilance system, such as National Competent Authorities, Marketing Authorisation Holders and Sponsors of clinical trials. The European Medicines Agency (EMA) will launch a new and improved version of EudraVigilance with enhanced functionalities for reporting and analysing suspected adverse reactions….

Patients worldwide constantly expect new, effective and safe therapies. Access to modern drugs would not be possible without clinical trials – a significant element of the drug marketing authorization process. Clinical trial and post-market trials are the foundation of contemporary medical science and “pivotal” in the drug development process. They are a pre-condition of patients’…

seQure Life Sciences presents the current pharmacovigilance legislation in Europe:

©2017 - seQure - All Right Reserved - Privacy Policy - Cookie Policy