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….

Leadership in the Workplace: Angela Weston International Women’s Day takes place on March 8th and is an important day in the calendar as it celebrates the social, economic cultural and political achievements of women.  It’s theme this year is “An equal world is an enabled world”. Women today are still striving to close the gap in…

Verona, Italy (25 February 2020) – In response to the news from the Italian Authorities, PM Holding Companies (CROS NT, Arithmos, seQure) are taking the following actions as a precautionary measure in our Italian offices with immediate effect: STAGE 1: Team Lead Mapping A complete mapping of staff, internal and external, has been done. For strategic…

Verona, Italy (30 January 2019) – PM Holding, a group of diverse service providers in the life sciences industry, announces the appointment of Jan Back as Marketing Director to manage marketing across the entire group. PM Holding consists of specialized service providers in the drug and device development sector including: CROS NT (global, expert biometrics…

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…

The Regulation (EU) 2017/745 (also known as MDR) transition time of three years is about to end – by May 26th 2020 manufacturers of currently approved medical devices need to meet the requirements of the regulation. However, a lot of questions on the compliance procedures have emerged during this transition period. In order to support…

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