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…

What is GCP GCP stands for Good Clinical Practice, a set of standards for designing, recording and reporting trials that involve the participation of human subjects. Compliance with these standards guarantees that the rights, safety, and wellbeing of trial subjects are protected and that clinical-trial data are credible (1). Regulation VS Directive The European Union…

CROS NT, seQure and Arithmos have become a corporate partner and members of the women’s association Verona, Italy (20 June 2019) – PM Holding, a life sciences holding company comprised of CROS NT, seQure and Arithmos, announced a corporate sponsorship and membership for all three companies with Healthcare Businesswomen’s Association (HBA). HBA is a global…

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…

We always aim at staying in close contact with the industry stakeholders and partners, so this October we traveled to Bologna, Italy for the Meet in Italy for Life Sciences conference, the leading national matchmaking and update event on Life Sciences. The Life Sciences sector in Italy is a crucial growth industry in Italy: the…

Many sponsors and  CROs conduct mock inspections to determine organizational inspection and audit readiness. Investing in a regulatory mock inspection demonstrates a serious commitment to patient safety, data integrity, and regulatory compliance. The primary goal of a mock inspection is to identify gaps prior to an actual inspection. Below, some tips to proceed in the right direction: 1) Put…

The GDPR – General Data Protection Regulation entered into force in May 2018. This regulation supplants the previous Data Protection Directive 95/46/EC, a formal set of guidelines concerning data privacy. The premise of the new regulation was to bring into line data privacy laws throughout Europe, while safeguarding the rights of EU citizens. GDPR also establishes both general…

At the end of 2017, as required by Italian Law No. 232/2016, AIFA approved new criteria for the classification of a drug as innovative, the assessment procedures and the criteria to maintain the qualification of “innovative”. The criteria identified by AIFA are: 1) Therapeutic need: to be considered “innovative”, the therapeutic need can be classified…

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