SafetyDrugs news: database and its implementation
Managing personal data in ICSRs requires structured control of regulatory data flows. GDPR and GVP Module VI Addendum II make masking and data minimisation a system architecture issue.
Disabling HTTP for EMA XML schemas impacts ICSR submission via Gateway and EVWEB. Here are the deadlines, technical impact, and compliance requirements.
The latest edition of SD Collection, the SafetyDrugs special with insights, updates and useful advice on pharmacovigilance is now available.
In September 2025, MedDRA version 28.1 was released, the [...]
GVP Module VI Addendum II issued by EMA introduces new rules on the processing of personal data in ICSRs submitted to EudraVigilance. Here is what changes and how to be compliant.
MedDRA 28.0 has been released: the latest version of the internationally adopted medical regulatory dictionary. Here are the main news.
An in-depth look at MedDRA: its structure, hierarchical levels, multi-axiality, and applications. Discover why it's a crucial tool in coding and analyzing pharmacovigilance data.
Pharmacovigilance data protection is an essential element and to guarantee security we have relied on Oracle for years.
The safety database is a fundamental tool for efficient pharmacovigilance ICSR management. Here are the main advantages of using it.
The ICSR transfer outside of EU entails risks in terms of compatibility between pharmacovigilance agreements and GDPR. Here's how be compliant.
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 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 [...]