SafetyDrugs news: database and its implementation
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.
More and more pharmaceutical companies or providers of pharmacovigilance [...]
When you begin to work independently on a new [...]
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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.
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.
Here are some valuable suggestions provided by Calin Lungu during the European Pharmacovigilance Congress on the management of duplicates.
We were in Paris, guests of the French affiliate of a multinational pharmaceutical company, for a training session on SafetyDrugs. Here are the reflections that emerged...
For its pharmacovigilance database, Max Application has chosen to rely on a data centre with the best safety standards, that of Oracle. Here because.
We presented SafetyDrugs 6, the new native ICH R3 version of our pharmacovigilance database, to our customers. Here are the questions that arose.
Three different statistical indicators, statistical significance tests, case reports from literature and much more. Here are the tools of our Business Intelligence.
Pharmacovigilance becomes accessible to everybody with Saas! Enjoy the on-cloud service, set it up and pay just for your real demands.
EMA postpones the entry into force of the ICH R3 regulations: this is what emerged at the round table organized by Asgenia where, to the users of SafetyDrugs, Max Application explained the migration to ICH R3.
The project manager Carlo Ghiglione replies to some questions about the switch to the new rules ICH R3. Here is what is important to know.