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…

The global spread of COVID-19 amongst other challenges has resulted in travel and work restrictions. This crisis has changed the way Life Sciences companies approach the GxP audits and forced them to look for new solutions that allow them to ensure business continuity and efficiently protect patients. One of these solutions is remote audits, which…

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…

This is the third blog in a new ‘Career Insights’ series and we spoke to Nicolò Figà Talamanca, seQure Business Development Manager, to find out more on his job, career path, achievements, and his hobbies. Can you say a couple of words about your work in seQure? My three areas of work in seQure are…

This is the second blog in a new ‘Career Insights’ series and we talk to Stefania De Santis, seQure Director of Pharmacovigilance, to find out more on her job, career path, achievements, and hobbies. Can you give us an insight into your work in seQure? My day is divided between work supervision, operative activities, and…

This is the first blog in a new ‘Career Insights’ series and we talk to Antonella Troysi, seQure Senior GxP QA Consultant, to find out more on her job, career path, achievements, and her hobbies. Can you give us an insight into your work in seQure? As QA consultant, I work directly with our clients….

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