Pharmacovigilance during pregnancy
Pharmacovigilance during pregnancy has a fundamental role. Pregnant women are excluded from clinical trials and therefore any data can be useful for drug profiling
Paediatric pharmacovigilance
Paediatric pharmacovigilance requires special attention due to the patients involved. Here's what it is and how to manage it.
Pharmacovigilance in special populations: geriatric patients
Special Populations are categories of patients that differ in age or in specific disorders. Consequently, the pharmacovigilance activity is more complex in their cases. It was discussed at the third edition of the European Pharmacovigilance Congress. Here is what Giovanni Furlan, Head of security risk, Director of Pfizer, reported on geriatric patients.
European Pharmacovigilance Congress: what we take home from the third edition
There was two days of congress rich in topics: [...]
In Milan, the third edition of the European Pharmacovigilance Congress
For the third consecutive year we will be the [...]
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 [...]
Medical devices: marketing authorization in USA and China
The American and the Chinese are the main Medical Devices market in the world. In these Countries the devices classification is different from the European one. How to proceed to obtain the marketing authorization?
Medical devices: 26th May 2020, a likely date?
A few months from 26th May 2020, the date of [...]
Medical devices and safety: what will change with the new rules
On 26th May 2020 the 2017/745 EU regulation on medical devices will entry into force. It was discussed at 59th AFI Symposium, the Italian event dedicated to pharmaceutical sector. Here is what emerged.
59th AFI Symposium: pharmacovigilance meetings not to be missed
As every year in June, the AFI Symposium, the [...]
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.
Safety database implementation: how long does it take to integrate SafetyDrugs into business processes?
This is a frequently asked question when a company is considering changing the old database with a native ICH R3 one. Here are the phases and times of integration of SafetyDrugs 6.
EudraVigilance, inspections and non-compliance: here is what to pay attention to
Back from the DIA Europe, which took place from [...]