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.
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.
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 requires special attention due to the patients involved. Here's what it is and how to manage it.
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.
There was two days of congress rich in topics: [...]
For the third consecutive year we will be the [...]
More and more pharmaceutical companies or providers of pharmacovigilance [...]
When you begin to work independently on a new [...]
It takes just four days to learn all that [...]
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?
A few months from 26th May 2020, the date of [...]
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.
As every year in June, the AFI Symposium, the [...]
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.
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.
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.
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.