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studio osservazionale

Classification and performance of drug observational studies

On 8 August 2024, AIFA published Decree no. 425/2024. The scope of this Decree, considering the different legal and regulatory...

Registrazione DM nel database ministeriale

Registration of medical devices in the database of the Italian Ministry of Health

As established by the Ministry Decree 21 December 2009, Changes and integrations to decree 20 February 2007 laying down the...

Pharmacovigilance: in-house or outsourced? Challenges and opportunities for pharmaceutical companies in the era post-Directive 2010/84.

After Directive 2010/84 has become effective, pharmacovigilance landscape has deeply changed. Pharmaceutical companies find themselves to face a complex and challenging...

Serializzazione e tracciabilità

Serialization, state of the art

A webinar held on 8th May took the stock of the situation of the serialization for drug traceability, provided for...

Medicinali Critici

Shortages and lists of critical medicines – AFI and EIGP conference

The scope of the event “Conference on shortages and lists of critical medicines”, sponsored by the pharmaceutical trade associations AFI...

Class I medical devices between Directive and Regulation

Regulation (EU) 2023/607 has amended Regulation (UE) 2017/745 (MDR) extending the transitory period and defining the criteria to benefit from...

Farmaci Orfani

Rare diseases and Orphan drugs

A meeting was held on 17 April 2024 in the hall of the “Last Supper” at the Italian Chamber of...

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...

documenti di origine esterna

Documents of external origin. How to manage the legislative updating process

For a Medical Device and In Vitro Diagnostics manufacturer, keeping up with continuous legislation changes that characterize this sector at...