flexible workload from 4 to 360h
valid certificate in your country
What will I learn?
This focused Pharmacovigilance Course equips you with practical skills to handle safety for oral antidiabetics, using the new product GlucoSafe as a real-world example. You will learn key PV concepts, ICSRs, causality, seriousness, and expectedness, then apply them to signal detection, risk evaluation, regulatory reporting, and internal communication to support compliant, data-driven safety decisions in your daily work.
Elevify advantages
Develop skills
- Master ICSRs: capture, code, and submit high-quality antidiabetic safety cases.
- Apply signal detection: spot, prioritise, and manage safety risks from small datasets.
- Perform causality and seriousness ratings using WHO-UMC, Naranjo, and FDA/EMA rules.
- Interpret DILI labs and antidiabetic safety profiles for rapid clinical risk decisions.
- Execute compliant FDA/EMA reporting, narratives, and internal PV communication.
Suggested summary
Before starting, you can change the chapters and workload. Choose which chapter to start with. Add or remove chapters. Increase or decrease the course workload.What our students say
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