The purpose of this training is to better understand the new obligations of Marketing Authorisation Holder's towards European Union Risk Management System regulation by getting the objectives and the key concepts of the GVP Module V in relation with the GVP module VIII and the GVP module XVI.
MAH, Risk Management System, RMP, European GVP module V, EU
LEARNING OUTCOMES
At the end of this course, you will be able to:
Know all major concepts/definitions
Understand new Risk Management System requirements
Use properly the ad hoc new template
Develop more appropriate risk minimisation tools
Identify which of your company's product is concerned by a Risk Management Plan
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