The purpose of this course is to give you knowledge and expertise of the general philosophy of the European Guideline of the good pharmacoVigilance Practices (GVP), and particularly new obligations of Marketing Authorisation Holder's as described in the GVP Module IX called Signal Management.
MAH, Signal Management, EU Pharmacovigilance Network, European GVP Module IX
At the end of this course, you will be able to
Know thoroughly definitions of signal and signal management process
Comply with all steps of the signal management process
Understand the importance of tracking all actions/decisions
Identify which structures and processes are involved in the European Union Pharmacovigilance network