The purpose of this course is to enable you to know the general philosophy of the European Guideline of the good pharmacoVigilance Practices (GVP), and particularly to better understand the new obligations of Marketing Authorisation Holders related to Post-Authorisation Safety Studies (PASS) by getting:

•  the general framework of European regulations governing post -authorisation phase
•  the objectives and the key concepts of the GVP Module VIII alone, plus Addendum I (Member States' requirements for transmission of information on non-interventional post-authorisation safety studies)
•  some inside views on the PASS implementation in industry.

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

• Know all major concepts/definitions

• Follow strictly the recommendations related to the content of study protocol, abstract and study reports for non-interventional Post-Autorisation Safety Studies imposed as a condition to the marketing authorisation

• Know the reasons for imposing Post-Autorisation Safety Studies and the role of Pharmacovigilance and Risk Assessment Committee (PRAC)