New Annex 1, among other important points considered, dedicates several comments on the importance and the impact of Critical Utilities, involved at different level either because directly impacting on Contamination Control Strategy (CCS) document, or because potential direct or indirect source of bio-contamination of the final product.
EU MDR 2017-745: New Cybersecurity Requirements for Networked MD producers by Danilo Maruccia, Executive Consultant & Business Partner – PQE Group As EU MDR 2017-745 Regulation deadline is approaching, cybersecurity for Medical Devices has become a main concern for all Networked Medical Devices manufacturing companies. In the video below, we’ll review the most important requirements […]
European Medicines Regulatory Network agreed to proceed with the extension of the Step 1 (risk evaluation) deadline to October 1st, 2020, due to Covid-19 spreading.
The art of working after Covid-19: a positive side effect from Covid-19 by Danilo Maruccia and Pierre Crivelli Last decade brought market evolution with itself, and a race for research and development to increase opportunities, optimize costs and improve efficiency in the way leaders do business and manage their companies. This heritage comes from 2008 […]
What is SARS-CoV2 from Genetics perspective and how did it evolve from animal to human? by PQE Group’s Infodemic Research Team Topic: Science Researchers: Valentina Izzo, Project Manager Madan Lal, Consultant Abstract The most significant component of a virus is its DNA/RNA, as it is essential for carrying information, its replication and survival in the […]
Medical Cannabis: a fast-expanding market by Emanuele Bertea, Paola Cinquanta, Giampaolo Mazzuca Last year, the Cannabis global market has shown a rapid expansion. Canada was the first country to regulate its Medical Cannabis industry and market – meaning the production and commercialization of the plant and its derivatives – and now Europe is following Canada’s […]