SafetyDrugs news: database and its implementation
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.
Here are the best features to look for understand how to choose a safety database
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 latest edition of SD Collection, the SafetyDrugs special with insights, updates and useful advice on pharmacovigilance is now available.
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.
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.
Many are the pharmaceutical companies that still store up pharmacovigilance data with spreadsheets. There are many reasons to leave Excel and switch to a native ICH R3 software. 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...