Operational calendar for regulatory deadlines: visibility and control
Products, countries, authorities and periodicities are not merely master [...]
MedDRA 29.0: what changes for pharmacovigilance
MedDRA 29.0 introduces complex changes, updates to existing SMQs and updates for pharmacovigilance data management. Here is what changes.
MIR 7.3.1: mandatory new format for medical device vigilance reporting
Starting May 1, 2026, MIR 7.3.1 is the new mandatory format for reporting incidents related to medical devices. The update impacts reporting systems and requires generating reports according to the new specifications.
How to calculate regulatory deadlines in a structured way with Chronisia
Find out how pharmaceutical regulatory deadlines (PSURs, DLPs, AIC renewals) are calculated and how to manage them in a structured way.
New FDA adverse event platform: what changes for pharmaceutical companies in pharmacovigilance data management
AEMS is the new FDA platform for adverse event data. It does not change submission processes, but increases data accessibility, making quality and structure more critical.
ICSR Submission to FDA: ICH E2B(R3) becomes mandatory from 1 April 2026
From 1 April 2026, ICSR submissions to the FDA must be sent in ICH E2B(R3) format. Learn what changes for pharmacovigilance systems and FDA ESG submissions.
Personal data in ICSRs: compliance is a matter of system architecture
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.
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.
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.
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.