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Lingua

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...

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...

Pubblicità Dispositivi medici

Advertising. Medical devices and IVDs

Does your company manufacture or is it responsible for the marketing of medical devices or IVDs and do they wish...

Autorizzare i Novel Food

What is a novel food and how to market it

Consumers’ food choices tend to vary in time and, especially in recent years, new types of foods have arrived on...

Foglio Illustrativo

PIL, a clear and readable source for information to patients

After doctors and pharmacists, the patient information leaflet is the main source of information on medicinal products available to consumers. However, in...