Smart Working: dealing with IT support implications

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 […]

Windows 7 to 10 migration strategy

How to deal with Windows end-of-life

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

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 […]

Cybersecurity for Medical Devices risks and vulnerabilities

Why MD Cybersecurity is so important

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 […]

Nitrosamines impurities risk evaluation

CMDh raising risk awareness on Nitrosamine Impurities

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.

FDA temporarily retreating on impurities for market shortage

FDA temporarily raising tolerance on impurities due to market shortage

FDA has issued setting temporary rules on a probable cancer-causing impurity formerly regulated. To avoid market shortage of Losartan, drugmakers will be able to make losartan with an impurity percentage above its prescribed level for six months while the supply of clean drugs is ramped up. A calculated risk, to preserve blood pressure drugs availability […]