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Quality management software validation in the iso 13485:2016

Medical Device manufacturers shall soon face relevant changes as provided for by the new European Regulation requiring, among other novelties,...

The 13th italian national meeting of pharmaceutical qualified persons (QP)

The 13th italian national meeting of pharmaceutical qualified persons (QP) was held last 28 November. The speeches of the AIFA officers Dr....

Easier clinical trials in the European Community?

In 2014 the European Parliament approved the Regulation on clinical trials on medicinal products for human use (Regulation 536/2014) with...

New strategies for medical device assessment

“New strategies for medical device assessment” is the title of a workshop presented in Rome on 4 October by Di Renzo...

Medical devices vulnerable to cyberattack

The US Food and Drug Administration has just launched an alert on the vulnerability of medical devices to hackers’ attacks, that...

What is the pharmaceutical regulatory activity

Great masters teach that the more you know a subject, the more easily you will be able to explain it....

A sworn translation, what it is and when it is required

You bought a car in Germany and its logbook is in German; you got married in Argentina and your marriage...

Brexit and the shortage risk in UK

The still uncertain situation of the exit of United Kingdom from the European Union is having negative effects on the economies of...

Food supplements containing curcuma

The Italian Ministry of Health has published new information to clearly report the labelling requirements to be complied with for food supplements containing...

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