Pharmacovigilance ICSR management: 10 benefits of the safety database
The safety database is a fundamental tool for efficient pharmacovigilance ICSR management. Here are the main advantages of using it.
ICSR transfer outside of EU: how to comply with the GDPR with SafetyDrugs
The ICSR transfer outside of EU entails risks in terms of compatibility between pharmacovigilance agreements and GDPR. Here's how be compliant.
Pajama Run 2023: let’s run together for cancer children
Pajama Run is an event organized by LILT to support children affected by cancer. Here's what it is and how we decided to support the cause.
Rally Lana 2023
Rally Lana 2023, the most awaited automotive event in the Biella area, took place in Biella from 21 to 22 July 2023. Here's how it went.
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.
MDR extension: clarifications on Regulation (EU) 2023/607
Following the introduction of the MDR extension, many doubts arisen for manufacturers. The European Commission has therefore published a Q&A dossier of clarifications. Here are the main points
MDR extension: the postponement of the transition period is official
Regulation (EU) 2023/607 extends the validity of the certificate of medical devices until 2027 or 2028 based on the risk class.
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.
Rally della Lana 2022
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: 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.