This course is an intensive two days pharmacovigilance training course with focus on GVP guidelines. The course will elaborate from current and draft GVP guidelines and system changes from the EMA implemented during 2018.
The course will elaborate on how these changes will affect the day-to-day pharmacovigilance operations within the pharmaceutical companies with practical examples, which will be based on real life situations regarding electronic transmissions, signal management and organizational aspects affected by new draft GVP modules and the EMA’s system changes.
LEARNING OBJECTIVES
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WHO SHOULD ATTENDThis course is valuable to professionals in drug safety with at least two years of experience, who wish to update their skills and enhance their knowledge by in- depth analysis of practical challenges and learn to implement solutions within ever changing pharmacovigilance environment:
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