GVP Module I - Pharmacovigilance Quality Management System
OBJECTIVES
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
to better understand the new obligations of Marketing Authorisation Holder's towards the quality system of the Pharmacovigilance system(s), GVP module I .
MAH, PV Systems, European GVP Module I, Quality system, Quality system tools, Retention Periods of PV Data or Documents
LEARNING OUTCOMES
At the end of this course, you will be able to
know the definitions of the different quality system tools and retention periods of PV data/documents
follow the recommendations on establishment and maintenance of a quality system related to MAH PV Systems
comply with the overall quality objectives and guiding principles
adapt the quality system to the concerned organisation.
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