Proposed amendment to the MDR: what changes for vigilance and surveillance
Technical analysis of the proposed MDR and IVDR amendment: what changes for vigilance, PMS, PSUR, cybersecurity, Eudamed and EMA.
SD Collection, the pharmacovigilance magazine
The latest edition of SD Collection, the SafetyDrugs special with insights, updates and useful advice on pharmacovigilance is now available.
EMA HTTP schema disabling: how to prevent issues in ICSR submissions
Disabling HTTP for EMA XML schemas impacts ICSR submission via Gateway and EVWEB. Here are the deadlines, technical impact, and compliance requirements.
European Pharmacovigilance Congress 2025: what to expect
The European Pharmacovigilance Congress is back, one of the key international events dedicated to drug safety surveillance. Here’s why we’ve chosen to take part again this year.
MedDRA 28.1: what’s new for pharmacovigilance from terminology to the Desktop Browser
In September 2025, MedDRA version 28.1 was released, the [...]
GVP Module VI Addendum II: how to comply with the new EMA Rules on ICSR data
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.
Pigiama Run 2025: running for pediatric cancer awareness
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.
Risk communication in pharmacovigilance: a new approach to managing EMs and DHPCs
How to improve the risk communication in pharmacovigilance? The "Rethink Safety Communication" Italian project suggests concrete solutions
Pharmacovigilance and data security: why we chose ISO 27001 certification
Data security in pharmacovigilance requires more than promises. Here’s why Max Application chose ISO 27001 certification and what it means for your company.
Risk Minimisation Measures (RMMs): the new approach in GVP Module XVI Revision 3
GVP Module XVI Rev. 3 redefines Risk Minimisation Measures (RMMs) with new tools, digital strategies, and stronger expectations for pharmaceutical companies.
AFI Symposium 2025: agenda, key topics and a focus on pharmacovigilance
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: what’s new in the latest version
MedDRA 28.0 has been released: the latest version of the internationally adopted medical regulatory dictionary. Here are the main news.
MedDRA: what it is and why it is essential in pharmacovigilance
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.
Thalidomide: the scandal that changed pharmacovigilance forever
The Thalidomide case shocked the world. From this tragedy, pharmacovigilance was born a system that today protects millions of people.
Artificial Intelligence and EMA: initiatives for use in pharmacovigilance
During 2024, EMA published tools and guidelines to integrate artificial intelligence into pharmacovigilance processes. Here they are.
EMA Account Management: new features and updates for easier and more secure management
During 2024, EMA Account Management, has introduced numerous new features to simplify the user experience and improve security.
EudraVigilance: updates and improvements for more efficient management
In 2024, changes were made to improve the quality of data managed and the operational efficiency of the system.
GVP XVI Review: risk minimization updates
The review introduces important updates relating to risk minimisation measures and their management.