Role of the Qualified Person Responsible For Pharmacovigilance (QPPV)
OBJECTIVES
The objective of this course is to present you the legal framework that governs pharmacovigilance and the central role of the QPPV in pharmacovigilance practice.
The lecture includes a brief discussion of all vigilances.
EUQPPV role, Regulatory bodies, MAH role, Pharmacovigilance System Master file (PSMF), QPPV responsibilities
LEARNING OUTCOMES
At this end of this course, you will understand the legal framework that governs pharmacovigilance and the central role of the QPPV in pharmacovigilance practice.