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,...
The European Medicine Agency (EMA) has been working on the digitalisation of regulatory processes for medicines for some time now,...
Law-Decree 11 January 2023 no. 4 was published in the Italian Official Journal no. 8. This provides for a time...
On 6 January 2023 the European Commission has adopted a proposal to change the provisions regarding the transitory period for...
We all know how it is important today to keep up with the times in either personal or working fields,...
On 9 December, the EPSCO (Employment, Social Policy, Health and Consumer Affairs Council) announced that an extension will be proposed...
The post-marketing surveillance (PMS) is a theme that is becoming more and more important in the frame of medical device...
Eudamed: european database of medical devices. It is the unique database of medical devices and it is intended to collect...
One of the essential elements to manage a risk of non conformity with the regulation inside a company are corporate...
The long process leading to the availability of a medicinal product on the market includes a whole set of steps...