by Tepsivo | Mar 21, 2025 | Blog
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...
by Tepsivo | Mar 12, 2025 | Blog
No time to read now? -> Download the article as a handy pdf List of contents Introduction Part 1: A lot of valid questions Part 2: Drop in the number of safety reports The assessment plan outline Full compliance, insightful learnings Part 3: Number of hits / safety...
by Tepsivo | Feb 28, 2025 | Blog
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...
by Tepsivo | Jan 30, 2025 | Blog
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...
by Tepsivo | Dec 9, 2024 | Blog
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...
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