A safety database is a fundamental tool for complying with pharmacovigilance regulations, allowing you to save time and resources. Here it is the reasons why a safety database is convenient for pharmaceutical companies.
The two Italian National Ethics Committees for clinical trials will evaluate the study protocols of their respective competencies on a monthly basis.
Citizens can now always be updated on any shortages of medicines thanks to AIFA Medicinali.
Medicinal products, although useful for the treatment of diseases that can afflict humans, are not free from possible risks and side effects. It is, therefore, necessary to constantly supervise the relationship between the expected benefit and the possibility and the degree of risk of each drug. Pharmacovigilance deals with this activity. Here is in detail what it is.
The Rally della Lana is approaching its 35th edition. The 7 special stages will be held in the Biella area from 29 to 30 July 2022.
Educational material was a topic addressed in the Pharmacovigilance session of the 61st AFI Symposium. Here's what emerged.
AIFA is ready! The Italian Medicines Agency has announced that the new Italian National Pharmacovigilance Network will be available.
One of the various aMMRs is the dissemination of educational material to doctors and patients. Here's how to manage it and who are the actors involved.
As per tradition, the AFI Symposium dedicated a session entirely aimed at pharmacovigilance. Here's what emerged.
The AFI symposium returns to the Palacongressi in Rimini from 8 to 10 June 2022. As usual, there will be 3 days of scientific sessions accompanied by workshops and round tables. Here is the program.
The EDQM standard terms will be mandatory starting for the indication of dosage forms and routes of administration in pharmacovigilance reports. Here's the news.
Thanks to an EU Regulation, the European Medicines Agency has now the means to strengthen the tools against shortages of medicines and medical devices. Here are all the news.
Juggling architectural barriers and various obstacles will no longer be a problem for people in wheelchairs, thanks to the Open Social Navigator.
The 30th edition of one of the most important events for the pharmaceutical sector was held at Fiera Milano. We were there, here's how did it go.
At 6 months after the first administrations, 423 are the reports of fatal events, but only 7 are confirmed. Here is the full AIFA report.
After Brexit there were numerous doubts regarding the data flow from EU to UK: in fact, since it is no longer part of the European Union starting from January 2021, it was necessary to find an agreement between the parties, so that European data can circulate safely on British territory.
From today, the MDR, the new European Regulation on Medical Devices, that came into force in May 2017, has full applicability. After a one-year postponement due to Covid, it wonders how the various actors involved in the fulfilment of the new duties required by EU Regulation 2017/745 are.
The MDR, which replaces the old Directive, implements several new features. Here they are.