Preparation of the Periodic Safety Update Report (PSUR) is one of the new requirements introduced with the Medical Device Regulation (MDR). Although it shares the name with the well-known periodic safety report for medicinal products, its format and content are specifically tailored for the medical device. This webinar offers practical guidance to the latest PSUR…

Regulation (EU) 2017/745 also known as the MDR, applicable since May 26th 2021, introduced a new obligation for the medical device manufacturers – according to the Article 86, they are obliged to prepare the medical device Periodic Safety Update Report (PSUR) for medical device classes of risk IIa, IIb and III. As the MDR has…

We are excited to announce that Antonella Ursini, seQure’s Managing Director, will be speaking at Italian Pharmacovigilance Day 2021. This year, the event will take place online on the 12th of October and focus on the following topics: Real World Data, big data, and their impact on pharmacovigilance Regulatory evolution Technology evolution and its impact…

Dear all, Hopefully you have read the recent press release published on the website of our sister company CROS NT (a PM Holding company) which was acquired by Alira Health, a leading international healthcare, and life sciences advisory services company. CROS NT will leave PM Holding and become part of Alira Health’s complete end-to-end offering,…

Crucial for safeguarding the health of the patients and safe use of the drug, case processing becomes increasingly difficult and time-consuming, as the volume of AE reports increases exponentially. Optimisation of this work will allow your team to cope with the growing amount of work while maintaining a high quality of case processing. Join our…

From on-site audits to remote audits 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…

On the 27th of April, we conducted the webinar “Practical Advice for Your Next Remote GVP Audit”. In this webinar, we shared the best practices in planning, conducting, and reporting remote audits based on our own experience, analysed how remote audits evolved through 2020, and answered the questions of the participants. Continue reading to discover…

In seQure, our vision is to build a world where all patients receive safe medicine they can trust. Our team is what distinguishes us from other industry providers. In this blog, we asked some of our colleagues to share their favourite part of their job and connection to our goal – support our clients in safeguarding…

This is the new blog in our ‘Career Insights’ series and we spoke to Andrea Berardi, seQure’s Senior GxP Consultant & Auditor and CSV Consultant, to find out more about 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…

What are the major pitfalls of GVP remote auditing and how should you address them? Why time management is crucial for remote audits? What tools are indispensable for a successful remote audit? Watch our webinar “Practical Advice for Your Next Remote GVP Audit” to find answers to these and many other questions related to effective…

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