MedDRA 29.1 introduces changes to medication error classification, LLT currency status and existing SMQs. This article examines the key updates and their operational implications for pharmacovigilance coding, safety data analysis and safety databases.
Chronisia transforms regulatory deadlines into an operational calendar, linking commitments, tasks, dashboards, and audit trails.
Find out how pharmaceutical regulatory deadlines (PSURs, DLPs, AIC renewals) are calculated and how to manage them in a structured way.
When products, countries, procedures and responsibilities increase, Excel is no longer enough to govern regulatory deadlines. Here is how Chronisia turns dates, rules and tasks into a structured process.
We analyse key criticalities and the roadmap to improve DHPCs traceability and effectiveness.
AIFA has introduced a new pictogram to make DHPCs immediately recognisable in Italy. We analyse its composition, use across communication channels, and role in risk communication.
At the AFI Symposium 2026, pharmacovigilance will be at the centre of the discussion on Important Safety Communications. An opportunity to explore processes, traceability and discover Chronisia.
MedDRA 29.0 introduces complex changes, updates to existing SMQs and updates for pharmacovigilance data management. Here is what changes.
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.
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.
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.
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.
Technical analysis of the proposed MDR and IVDR amendment: what changes for vigilance, PMS, PSUR, cybersecurity, Eudamed and EMA.
The latest edition of SD Collection, the SafetyDrugs special with insights, updates and useful advice on pharmacovigilance is now available.
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.
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.