
Latest Articles
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…
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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…
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Vaping suspected for health consequences, needs regulation
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 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…
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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…
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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…
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EMA 2025 Regulatory Strategy
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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Chinese e-commerce ready to conquer the health market
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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Facebook opens to Pharma and MD ADV in Italy
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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EU: GDPR is now a reality
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 and SID&GP, together for Data Integrity guidance
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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Audit Trails Review: PQE leader of Pharma Coalition
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 wins the race to EMA over Milan
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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