Nitrosamines RA evaluation deadline extended due to coronavirus spreading
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.
Category: Pharma
Nitrosamine – Risk Evaluation: new deadlines for BIO and Chemical products announced
Nitrosamine Risk Assessment (Step 1): new deadlines for BIO and Chemical products announced by PQE Group As indicated in the latest updates on HMA.eu official website, the deadlines for Nitrosamine Risk Evaluation (STEP 1), formerly set on October 1st 2020 due to COVID-19 outbreak, have been newly updated as following: March 31st for Chemical medicines. […]
The art of working after Covid-19: a positive side effect from Covid-19
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 […]
Fight against SARS-CoV-2: treatments and prevention. What are the pros and cons of drug therapies?
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 […]
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 […]
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 […]
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 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 […]
The future of blockchain in healthcare
Blockchain is an increasingly widespread technology that is approaching a stage of maturity that could see an explosion of its use also in the health sector. The point of the situation has been published in “Blockchain in Healthcare Today (BHTY)”, which identifies the ten main trends of this evolution. Consolidation of startups and user education […]
Olive oil is a medicine according to FDA
Yes it is! Recently the U.S. Food and Drug Administration (FDA) has determined that there is credible evidence to support a qualified health claim that consuming oleic acid in edible oils, such as olive oil, sunflower oil, or canola oil, may reduce the risk of coronary heart disease. For this reason FDA decided to exercise […]