Pharmacovigilance news
Signal Management: the process phases
Signal Management is the process of managing safety signals in pharmacovigilance. Here's what phases it consists of and how it is performed.
Signal Validation: what is it and how to perform it
Signal Validation is the activity of verifying the reliability and completeness of the information supporting a potential signal. Here's how it's done according to GVP.
Signal Detection in pharmacovigilance: what it is and how it works
Signal Detection plays a fundamental role in the constant monitoring of the safety profile of a drug. Through this analysis it is possible to promptly identify possible signals of adverse effects associated with the use of a drug. Here's what Signal Detection is and how it's done.
How to choose a safety database: the guide
Here are the best features to look for understand how to choose a safety database
Why a safety database is convenient for pharmaceutical companies?
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.
Clinical trials: Italian National Ethics Committees are operative now
The two Italian National Ethics Committees for clinical trials will evaluate the study protocols of their respective competencies on a monthly basis.
Drug shortages: the app for notifying patients is now available
Citizens can now always be updated on any shortages of medicines thanks to AIFA Medicinali.
Pharmacovigilance: how it works
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: the point of view of the pharmaceutical company and the patient
Educational material was a topic addressed in the Pharmacovigilance session of the 61st AFI Symposium. Here's what emerged.
AIFA: new italian National Pharmacovigilance Network coming soon
AIFA is ready! The Italian Medicines Agency has announced that the new Italian National Pharmacovigilance Network will be available.
Risk management and educational material as aMMR
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.
AFI Symposium 2022: the vigilance at 360°
As per tradition, the AFI Symposium dedicated a session entirely aimed at pharmacovigilance. Here's what emerged.
61st AFI Symposium: the program
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.
EDQM standard terms: mandatory for Dosage Forms and Route of Administration
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.
Drug shortages: the measures for EMA to tackle them
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.
CPhI Worldwide: the balance of the 2021 edition
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.
Covid vaccines: this is what the AIFA report reveal after 6 months of administration
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.
Data flow from EU to UK: the European Commission decision arrives
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.