Event titled “Breaking Down The Silos: Product Development Journey through Post-Marketing: EMA vs FDA” will take place in Madrid on 10-11th 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…

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…

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…

To commercialize and take a drug to market, pharmaceutical companies are subject to stringent regulations that aim to protect the patients. This puts pressure on Sponsors to respect complex rules and regulate the entire “life cycle” of a drug – from development to authorization and post-market surveillance.During the last years, a lot of drug regulations came into effect in…

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…

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