In pharmacovigilance, case processing is a fundamental activity. It 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…

We are excited to announce that due to the high demand we will be repeating our webinar titled “Importance of Quality Case Processing in Pharmacovigilance Operations”.  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…

Pharmacovigilance is a vital part of the development of the new medicinal products. It makes sure that these products benefit the health of patients worldwide in safe and effective manner. With the increasingly stringent regulations and growing importance of patient centricity, pharmacovigilance plays now a much more central role than 10 or 20 years ago….

Request the white paper “Outsourcing in Pharmacovigilance: Why and How?” With the development of new technologies and continuous investments in R&D, the pharmaceutical industry displays stable growth for the past years. However, industry growth also brings an increase in the amount of challenges and their complexity. Among them, we could single out two challenges that have…

Join us for 2020 RQA International QA Conference on 10th-12th November! This year’s theme is ’20/20 Vision: A New Frontier?’ and the participants will have a possibility to join the event directly from their desks. We have a pleasure to participate as speakers – Antonella Ursini, our Managing Director, will be presenting a speech titled “Facilitating…

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…

An amendment to the Regulation (EU) 2017/745 (also known as MDR) was adopted on 24 April 2020 by European Commission, which postponed the application of most of its provisions by one year, until 26 May 2021. Originally,  the manufacturers of currently approved medical devices needed to meet the requirements of the regulation by May 26…

COVID-19 pandemic forced companies to explore how to survive while ensuring business continuity and protecting the health of their employees. We talked to Paolo Morelli, CEO of PM Holding (Arithmos, CROS NT, seQure), in order to understand what business owners can do to mitigate the impact of the pandemic on their operations, ensure business continuity,…

This is the new blog in our ‘Career Insights’ series and we spoke to Andrea Berardi, seQure GxP QA and CSV Consultant, to find out more on his job, career path, achievements, and his hobbies. Have you always been passionate about Life Sciences field? I can certainly say that I have. In fact, after graduation…

On the 22nd of November 2017, the European Medicines Agency (EMA) launched a new version of EudraVigilance. The improvements and changes affected users of the EudraVigilance system, such as National Competent Authorities, Marketing Authorisation Holders and Sponsors of clinical trials. You can read more about the updated EudraVigilance system here. Currently, ICSRs are accepted in…

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