Signal Management in Pharmacovigilance 2016

The course will teach basic concepts of signal detection and signal management and how to apply them within the participants' functions, including the data mining techniques for large volume ADR data analysis, relevant EMA guidelines as well as a future outlook. The entire course is updated in line with the latest guidelines on EU Good Pharmacovigilance Practices (GVP): Module IX - Signal management, Commission Implementing Regulation (EU) No. 520/2012, and CIOMS VIII. Time has been set aside for exercises, questions and discussions. What you will learn - Signal detection - Theory, methods, data mining - Signal management - Detection, triage, evaluation, further action - Signal management - Regulatory expectations - Signal management process: Strategy for implementation