SafetyDrugs news: database and its implementation
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.
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.
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.
Coronavirus forces MedDRA 23.0 to an unexpected urgent update
It was released just few hours ago the news of an update of 23.0 MedDRA dictionary version. The Coronavirus (COVID-19) pandemic has prompted an urgent need for a harmonized and standardized approach for the coding and reporting of infection as a global health issue.
EMA: from 30 June 2022 the ICH E2B (R3) becomes mandatory
Several years have passed since they started talking about ICH E2B (R3): the first guide was issued in 2014, in November 2017 the transition period began and today the date of the definitive transition is announced.
How much does SafetyDrugs cost?
More and more pharmaceutical companies or providers of pharmacovigilance [...]
How the SafetyDrugs assistance service works
When you begin to work independently on a new [...]
Learn to use the ICH R3 database in four days
It takes just four days to learn all that [...]
Simple database validation with our help
In the ICH R3 transition is essential the validation of the entire process. It is a delicate phase in which different areas are involved. In fact, it is related both to the installation of the environments, to the data conversion, and to the functioning of the software. We see below the situations in detail.
Here’s how we safely convert your data into R3
When switching to the R3 database the implementation consists also in migration and conversion of the data. It is a delicate operation that requires a path to be defined shared with the customer. Let's see how we approach thi delicate issue with SafetyDrugs 6.
Find out if SafetyDrugs is the most suitable ICH R3 database for you
Whether it comes from an Excel spreadsheet or a software, the change always raises numerous questions. So we wanted to explain what to expect during the analysis of the new product.
Pharmacovigilance cases management with Excel: here’s why it’s not the best choice
There are several companies that handle pharmacovigilance cases management with Excel, but there are many reasons why this is not the most suitable choice. Here they are in detail.