The two Italian National Ethics Committees for clinical trials will evaluate the study protocols of their respective competencies on a monthly basis.
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.
Educational material was a topic addressed in the Pharmacovigilance session of the 61st AFI Symposium. Here's what emerged.
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.
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.
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.
With the entry into force of the MDR there are several areas that have been revised as they are treated more roughly in the old Directive, among these there are also the information supplied with the device: in order to present the correct use of your device , each manufacturer is in fact required to affix on labels, packaging and instructions for use, all the information necessary for its use, such as the risks and benefits, operating methods, CE mark, etc. Let's see the updates.