Webinar – Materiovigilance: Everything you need to know about the new European Regulation on Medical Devices (EU Regulation 2017/745)
Language – French This webinar aims to provide clarification on the new EU Regulation on medical devices (EU Regulation 2017/745) which came into force on 25 May 2021. The new regulation outlines a more robust classification system for medical devices and sets out specific requirements for manufacturers, importers, and distributors of medical devices. This webinar […]
New rules on the temporary use authorisation (Autorisation Temporaire d’Utilisation, ATU) in France explained!
In 1994, the temporary use authorisation program was first implemented in France to allow early access to medicines for patients with serious or rare diseases when no authorised therapeutic treatment was available. Initially the ATU established to ensure patient access to human immunodeficiency viruses (HIV) therapies, and today it has expanded to cover all major […]
Stéphanie Le Guillou, PharmD, PhD Medical Content Manager, Cherry for Life sciences, a subsidiary of Universal medica group. How is your job role support Universal Medica Group mission of improving patient safety and wellness? I am managing the editorial line of 3 websites of the group. Santé sur le Net a public health website with […]
The emergence of COVID-19 and the economic consequences and travel restrictions that this pandemic has caused have led pharmaceutical companies to review their audit methods. Remote pharmacovigilance auditing has been implemented exponentially, but what are its Strengths and limitations? Strengths: Maintain audit planning (internal, contractors) in any circumstances (pandemic or other crisis situations…), more flexibility […]
The Jardé law, voted in March 2012, aims at giving a legal and statutory framework to clinical trials which involve people. Universal Medica summarizes for you the main points of the decree number 2017-884 of May 9th, 2017 which modifies certain arrangements. Creation of 3 new categories With the Jardé law, the “Biomedical Research (called […]