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…

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 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…

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…

On the 10th of October the top industry professionals gathered in Madrid, Spain, for Regulatory Day, an immersive workshop organized by seQure in collaboration with other PM Holding companies and its partners Oracle Health Sciences and Asphalion. The event, entitled “Breaking Down The Silos: Product Development Journey through Post-Marketing: EMA vs FDA” brought together the…

Verona, Italy (11 September 2019) – PM Holding, a group of diverse service providers in the life sciences industry, announces the appointment of Angela Weston as Chief Commercial Officer to manage business development operations across the entire group. PM Holding consists of specialized service providers in the drug and device development sector including: CROS NT…

Event titled “Breaking Down The Silos: Product Development Journey through Post-Marketing: EMA vs FDA” will take place in Madrid on 10th October The PM Holding group of companies including CROS NT, Arithmos, and seQure are excited to announce a Regulatory Day workshop, a unique event in collaboration with Oracle and Asphalion that focuses on the…

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