Overview
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.
Participants will be provided with preparatory material in order to better participate at the group exercises onsite.
Participants are kindly requested to read the GVP Module IX before the course.
What participants from previous courses say:
“The teacher was perfect, he answered all questions, and the training was very interactive.”Emmanuelle Bondon, Pharmacovigilance Project Manager, Universal Medica
"Very well organized, good facilities, great lecturer. The sessions always had an interactive part, which turned the course much more dynamic, promoting the discussion with colleagues from different types of companies and different backgrounds."
"This course was the best training for signal detection management what I have ever attended."
Dorota Zlochova, PV and Medical Affairs officer CEE, Chiesi Pharmaceuticals GmbH
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