The objective of this training is to enable you to better understand the obligations of MAH's on Periodic Safety Update Reports so often called PSUR as described in the GVP Module VII - Rev 1.

At the end of this course, you will be able to

• Understand and apply all major concepts relating to benefit risk evaluation, modular and risk based approach

• Use the properly ad hoc template

• Identify all the various types of Periodic Safety Updated Report assessment procedures depending on the products

• Be aware of new changes contained in GVP Module VII - Rev1