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Lingua

Digitalizzazione farmaci

EU RA procedures go digital: the new application form format (eAF) and the new product data format (PMS)

The European Medicine Agency (EMA) has been working on the digitalisation of regulatory processes for medicines for some time now,...

Carenza dispositivi medici

Medical device pay-back, latest news

Law-Decree 11 January 2023 no. 4 was published in the Italian Official Journal no. 8. This provides for a time...

Change of the MDR and IVDR transitory period: where are we?

On 6 January 2023 the European Commission has adopted a proposal to change the provisions regarding the transitory period for...

Meddra

The globalisation of pharmaceutical terms (MedDRA)

We all know how it is important today to keep up with the times in either personal or working fields,...

New proposal to extend MDR and IVDR transitional period?

On 9 December, the EPSCO (Employment, Social Policy, Health and Consumer Affairs Council) announced that an extension will be proposed...

Linee guida MDR

Implementation of post-marketing surveillance: MDR and guidelines

The post-marketing surveillance (PMS) is a theme that is becoming more and more important in the frame of medical device...

Registrazione in eudamed

EUDAMED – healthcare progress finds his way also through the european database of medical devices

Eudamed: european database of medical devices. It is the unique database of medical devices and it is intended to collect...

Consigli per scrivere SOP

How to draft a SOP

One of the essential elements to manage a risk of non conformity with the regulation inside a company are corporate...

Revisione linguistica

Translation and control of product information during European procedures

The long process leading to the availability of a medicinal product on the market includes a whole set of steps...

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