AIFA, the Italian medicines agency, has recently embarked on a significant reform: a process of restructuring governance to promote investments in pharmaceutical research and development and accelerate drug approval processes. Here are the details.
The safety database is a fundamental tool for efficient pharmacovigilance ICSR management. Here are the main advantages of using it.
The ICSR transfer outside of EU entails risks in terms of compatibility between pharmacovigilance agreements and GDPR. Here's how be compliant.
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 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.
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
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.
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.