SMART quality & compliance
Brexit and its impact on Pharma Compliance
The definite impact of Brexit on the Pharma Industry is, for the moment, vague. What is clear though, is that Brexit will have a big impact on the pharma supply chain and pharma compliance bodies. Due to Brexit the EMA must move to a new location, which is Amsterdam. All pharma compliance bodies which need to sit in an EU-country need to also move e.g.: QP, QPPV, Regulatory Affairs, etc. One advantage is, that after Brexit, the MHRA is only allowed to do inspections for medicines sold on the UK market like the FDA. It will be a long process…
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SMART quality & compliance
Same but different – implementation of a track-and-trace serialization of pharmaceuticals in the US
End-to-end vs. Track-and-trace verification The ever-growing threats of illegal (falsified or substandard) pharmaceuticals entering the legal supply chain require specifications of systems effectuating measures to improve patient safety. These are defined by national and / or supranational legislative institutions. The falsified medicines directive by the EU (2011/62/EU, including the Commission Delegated Regulation (EU) 2016/161) requires the implementation of an end-to-end serialization of pharmaceuticals to prevent falsified medicines from entering the legal supply chain (click here to read more on the EU directive). In the US, the Drug Quality and Security Act (DQSA) was signed into law in November 2013. As part of this…
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SMART quality & compliance
Patient safety first – a new EU directive to protect public health from falsified medicines
By Asemi – By our camera, CC BY-SA 3.0, Link “It is health that is real wealth and not pieces of gold and silver.” Mahatma Gandhi Imagine you have a bacterial infection and require therapy using antibiotics. Instead of obtaining the antibiotics and dosage you require, you receive substandard or falsified medicine, which for various reasons does not ease your infection or has previously non-described side effects on your health. While you might feel like this is a cautionary tale to raise your awareness for the fact that falsified medicines exist, this is a real-life problem which has become more…
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SMART quality & compliance
Data Privacy In The Age Of Digital Health
“Without privacy there is no trust, which is what the best individual healthcare requires” – Florian Schnettelker What do you think is the most valuable asset of every patient in the world? The thinking behind this question is shown in the implementation of digital health functions and solutions in the company and its products. The most valuable asset for a patient is his/her personal health data. This topic becomes more and more important with the rise of digital health solutions in our daily personal and business life. Laws and Regulations In many countries there are laws and regulations issued in…
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SMART quality & compliance
15th DIA Conference on European Electronic Document Management
Two of our consultants recently represented KVALITO at the 15th DIA Conference on European Electronic Document Management, held on December 2-3 in Berlin, Germany. A wide range of interested parties attended the conference, from big pharma (Pfizer, Sanofi, Bristol-Meyers Squibb, GSK, Bayer, Novartis, Roche), health authorities (FDA, BfArM, Egyptian Ministry of Health, MHRA), providers and vendors, to hear new information about electronic document management in the area of clinical trials and pharmacovigilance. Key topics that emerged from the conference presentations and discussions included: Upcoming EU Clinical Trial Regulation: Discussion and presentation about the upcoming clinical trial regulation and its impact…
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