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How often should you download ICSRs from EudraVigilance?

How often should you download ICSRs from EudraVigilance?

No time to read now? -> Download the article as a handy pdf List of contents Introduction Safety Data Collection in Europe Signal Detection and Validation How often should the ICSRs be downoaded? Communication with EMA The Case for Frequent Downloads Easier to...
2025 is the Year of AI in Pharmacovigilance

2025 is the Year of AI in Pharmacovigilance

No time to read now? -> Download the article as a handy pdf List of contents Introduction Tepsivo’s AI Journey The Idea of Tepsivo AI Test Results of AI in Drug Safety Assessment Our Learnings What’s Next for AI in PV? 2025 is the Year of AI in...
Amendment of EU PV Regulation in 2025

Amendment of EU PV Regulation in 2025

No time to read now? -> Download the article as a handy pdf List of contents Introduction What to expect? EMA signal pilot is ending Public feedback for the amendment Amendments with Tepsivo’s commentary Amendment 1 Amendment 2 Amendment 3 Amendment 4...
Analyzing Compliance Language: What are GxP requirements?

Analyzing Compliance Language: What are GxP requirements?

No time to read now? -> Download the article as a handy pdf List of contents Introduction GxP in EU Legislation GVP in EU Legislation GDP and GMP in EU Legislation GCP in EU Legislation Referring to Legal Requirements in GVP Recommendations and Requirements in GxP...