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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.
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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.
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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…
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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…
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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…
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National Heart, Lung and Blood Insititute (MD) revealed potential blood and respiratory consequences, Vaping reportedly involved in death and illness cases in Illinois; suspected long-term effects.
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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…
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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…
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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…
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European Medicines Agency (EMA), has published its draft of ‘Regulatory Science to 2025’ strategy for a six-month public consultation, following the workshop organized last October. This “Reflection Paper” is a proposed…
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With a value of 122.6 billion dollars in 2017, which in 2022 will reach a figure of 145 and 175 billion dollars, the Chinese pharmaceutical market was the second largest…
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Pharmaceutical and MD companies now have a brand new channel for their inbound marketing activities on the Italian market. In fact, after the new Advertising Guidelines issued by Italian Ministry…
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Published today in the Official Bulletin of the State, the legislative decree number 101/2018 aligns Italy to the GDPR rules that have been released on May 25th. The decree will…
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PQE Group is proud to announce that the draft of the new Russian Guide for Industrial Data Integrity has been published on the website of GILS – Russian State Institute…
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On Wednesday 27th of June has been presented at the 3rd PDA Europe Annual Meeting in Berlin a white paper about the issue of the Audit Trails Review. The ongoing…
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Amsterdam – At the end of the line, Netherlands’ capitol city won with a ‘coin toss’ the EMA assignment over Milan at the very final rush, with just 502 votes…
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