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…

The new ICH GCP E6(R2) addendum came into effect from June 14, 2017. The new addendum is the largest revision of the ICH GCP Guidelines over the past twenty years and it is fully supported by the European Medicines Agency (EMA). Previously, these guidelines were optional and the addendum now makes mandatory some activities related to Quality Management. With…

A Quality Management System (QMS) is a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. A Quality Management System helps to coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis. Implementing a quality management system affects every…

As of April 2017, the EU adopted the new Medical Device Regulation (MDR 2017/745), replacing the two existing directives, the Medical Devices Directive and the Active Implantable Medical Devices Directive: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002…

With the new ICH GCP E6(R2) addendum in effect from June 14, 2017, seQure Life Sciences would like to highlight: “The importance of a quality management system managed through a risk-based approach”.  The new addendum is the largest revision of the ICH GCP Guidelines over the past twenty years and it is fully supported by the…

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