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.
Every year, thousands of children and adolescents are diagnosed with cancer. Pigiama Run 2025 is a unique opportunity to bring together research, solidarity, and community.
How to improve the risk communication in pharmacovigilance? The "Rethink Safety Communication" Italian project suggests concrete solutions
Data security in pharmacovigilance requires more than promises. Here’s why Max Application chose ISO 27001 certification and what it means for your company.
GVP Module XVI Rev. 3 redefines Risk Minimisation Measures (RMMs) with new tools, digital strategies, and stronger expectations for pharmaceutical companies.
From June 11 to 13, the Rimini Palacongressi will host the 64th AFI Symposium: a complete overview of the scheduled sessions, with a special focus on educational materials in pharmacovigilance.
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.
The Thalidomide case shocked the world. From this tragedy, pharmacovigilance was born a system that today protects millions of people.
The latest edition of SD Collection, the SafetyDrugs special with insights, updates and useful advice on pharmacovigilance is now available.
During 2024, EMA published tools and guidelines to integrate artificial intelligence into pharmacovigilance processes. Here they are.
During 2024, EMA Account Management, has introduced numerous new features to simplify the user experience and improve security.
In 2024, changes were made to improve the quality of data managed and the operational efficiency of the system.
The review introduces important updates relating to risk minimisation measures and their management.
Throughout 2024, the European Medicines Agency (EMA) has spearheaded a series of projects aimed at improving the management of pharmacovigilance data. Here are the main innovations.
The European Pharmacovigilance Congress is the unmissable event to discover the latest news on pharmacovigilance, from regulatory challenges to technological developments. Here are the topics of this year.
With the entry into force of the AI Act, new rules are established for medical devices based on artificial intelligence (AI).
The Rally Lana 2024 took place on July 19 and 20, attracting drivers and enthusiasts from all over the world to Biella. Once again, SafetyDrugs renewed its role as the official sponsor of this prestigious event.