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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) – update July 2023

The European Medicine Agency (EMA) is working on the digitalisation of regulatory processes for medicines with the aim of facilitating...

Use of forbidden claims on food supplements

The use of food supplements in Italy is increasingly widespread, but at the same time the presence on the market...

Unindustria

Di Renzo Regulatory Affairs is part of Unindustria

Di Renzo Regulatory Affairs has become a member of Unindustria, a regional association that is part of the system of...

Sante DI Renzo

What are the regulatory affairs today?

It is a lesson from great masters that the more you know a subject the easier you will be able...

Ricerca scientifica per Farmaci Orfani

What are orphan drugs?

What are orphan drugs? Why are they important? Is there any incentive for their development? Orphan drugs are medicines developed...

Quality Management System for medical devices/in vitro diagnostics (DM/IVD)

The Quality Management System (QMS) is a control system, i.e. a set of activities aimed at verifying that the outcomes...

Payback e decreto bollette

Pay-back for MDs, new developments from the “Decreto Bollette”

The so-called “Bills Decree” (“Decreto Bollette” – Law-Decree 30 March 2023, no. 34 “Urgent measures to support families and enterprises...

Intelligenza Artificiale

Artificial Intelligence in medical devices: challenges and opportunities

The sector of Artificial Intelligence (AI) is continuously evolving, and in the next few years the impact of this new...

Time extension of the MDR and IVDR transitory period

On 20 March 2023, Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 was...