Fight against SARS-CoV-2: treatments and prevention. What are the pros and cons of drug therapies? by PQE Group’s Infodemic Research Team Topic: Science Researchers: Emanuele Volpe, Project Manager Valeria Famiglini, Consultant Abstract The Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has recently emerged as the etiological agent of Coronavirus Disease 2019 (COVID-19), which causes serious […]
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 […]
Smart Working: dealing with IT support implications by Dario Palese Current global health emergency situation is forcing the most of companies to maximize the smart working solution: In order to ensure the same performance whether working in the office or in smart working, IT services need to face this new reality. This means to refocus […]
The European Council and Parliament officially adopted an amendment to Regulation 2017/745, modifying the most of application dates to May 2021.
The second draft of GMP Annex 1 has been recently released and the issue date for the new revision is finally approaching. The document, a milestone standard for all sterile manufacturers, has been widely revised and extended.
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.
We consider the potential risks for Pharma and MD companies keeping their systems running on obsolete Windows versions and a good strategy to get up to date.
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 […]
Why MD Cybersecurity is so important? PQE Group – 3/12/2019 The hidden risks of a disruptive innovation. Is Cybersecurity important for Medical Devices? The answer is absolutely yes. But let’s move a bit backwards, to understand the reason why nowadays Cybersecurity has become a main concern for all Medical Devices producers. It’s well renowned that […]
On September 26th, 2019 the CMDh published the notice “Information on nitrosamines for marketing authorisation holders” asking to all Marketing Authorization Holders (MAHs) of human medicinal products containing chemically synthesised active pharmaceutical ingredients to evaluate the risk of the presence of nitrosamine impurities in their products. This includes generics and over-the counter (OTC) products.