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…

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 the new technologies in pharmacovigilance. A less noticeable…

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 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…

Pharmacovigilance Market size is expected to exceed USD 8 billion by 2024; according to a new research report by Global Market Insights, Inc. Growing number of adverse drug reactions (ADRs) coupled with increasing prevalence of chronic diseases will drive global pharmacovigilance market size. Below a snapshot from today to 2024: To download our infographic, click here. Continue…

Pharmacovigilance activities has long been fundamental to the pharmaceutical companies. As a result, demand for robust compliance systems and experienced talent have raised the cost of maintaining the infrastructure needed to support pharmacovigilance activities so, many companies decide to outsource some of their pharmacovigilance activities in order to improve effectiveness in managing their Pharmacovigilance Systems. For this…

Starting on the 22nd of November 2017, new improvements and changes will affect users of the EudraVigilance system, such as National Competent Authorities, Marketing Authorisation Holders and Sponsors of clinical trials. The European Medicines Agency (EMA) will launch a new and improved version of EudraVigilance with enhanced functionalities for reporting and analysing suspected adverse reactions….

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