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…

Pharmacovigilance and Digital Transformation: Growing Role of Technology Digital Transformation and Industry 4.0 – these are the topics regularly featured in titles of Life Sciences events and publications recently. While we talk a lot about technologies that disrupt drug development, clinical trials, and pre-clinical stage processes, it is difficult to come across materials dedicated to…

Pharmacovigilance Europe Congress 22-23 May 2018 London, United Kingdom 4th Annual International Conference and Exhibition in Pharmacovigilance, Regulatory Affairs, Risk Management and Clinical Trials Official Event Website.

Pharmacovigilance is the process of detecting, tracking, analyzing, and preventing negative side effects of drugs. Pharmacovigilance allows manufacturers and regulators to continue studying drugs and their effects after the drugs are released. With the global pharmaceutical market worth over $1 trillion and growing at a projected cumulative annual growth rate (CAGR) of 6% from 2014 to 2020, added to the increasing…

Pharmacovigilance activities have long been fundamental to companies seeking market approval in both the drug and device development process. For this reason, many companies decide to outsource some of the their tasks in order to improve efficiency in managing their Pharmacovigilance Systems. However, once you know what functions and expertise you want to keep in-house…

The new Clinical Trials Regulation n° 536/2014 was adopted in 2014. Due to technical difficulties in the development of computer systems, the “go live” date of the Portal was postponed and the EMA Board of Directors will identify a new date once the provider confirms the resolution of the issues. Therefore, the EU Clinical Trials…

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