Pharmacovigilance: Answers to the Frequently Asked Questions about Drug Safety
In a constant effort to promote awareness of the importance of this practice, we have collected and answered the most common questions relating to pharmacovigilance.
Pharmacovigilance: new funds expected from AIFA’s Board of Directors
The new AIFA Board of Directors recently announced the allocation of funds for pharmacovigilance and cybersecurity.
History of pharmacovigilance: evolution and progress in drug safety surveillance
There are numerous events that led to the birth of pharmacovigilance. Here is its evolution from its origins to today.
AIFA reform: what is it and who are the new members of the governance
AIFA has recently embarked on a process of restructuring governance to promote investments in research and development and accelerate drug approval processes.
SD Collection, the pharmacovigilance magazine
The latest edition of SD Collection, the SafetyDrugs special with insights, updates and useful advice on pharmacovigilance is now available.
Pharmacovigilance data protection: how we guarantee maximum security
Pharmacovigilance data protection is an essential element and to guarantee security we have relied on Oracle for years.
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.