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 […]

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 […]

Future of Blockchain in Healthcare

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 […]

OIL is a medicine for FDA

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 […]

EMA 2025 Regulatory Strategy Shaping Future Public consultation human stakeholders workshop

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 plan for advancing the Agency’s engagement with regulatory science over the next five to ten years, covering both human and veterinary medicines. The strategy will […]

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 in the world, after the US. A huge development that has not gone unnoticed by Alibaba, the Chinese colossus of e-commerce, who last June after […]

Facebook MD Pharma Campaign - credits: Armando Testa.

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 of Health, Facebook decided to open their platform to Pharma OTC and OTC-MD adv campaigns: a huge B2C market is about to be at reach […]

GDPR General Data Protection Regulation PQE Pharma DOTS

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 be active from September 19, 2018 and aims to bring a step forward for the transparency in the relations between patients and health service; as […]