Good Pharmacovigilance Practices (GVP)

Quality and Pharmacovigilance Systems

This course “serves up” an in-depth look at quality and pharmacovigilance systems. Just like a high-end restaurant relies on a well-run kitchen and attentive wait staff, this course will explore how these systems work together to deliver safe and effective medication. You’ll learn how the “kitchen” (quality system) ensures consistent preparation, and how the “wait staff” (pharmacovigilance) monitors patient well-being.

CEU Credits: 0.1
Course Code: ELM-939
Duration: 15 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0
Effective Date: 01/05/2024

Curriculum for this course


Pharmacovigilance systems
1 min 50 secs
Setting up a quality system for pharmacovigilance
46 secs
Quality cycle and objectives
55 secs
Additional groups
1 min 15 secs
Record management
30 secs
20 secs
Relationship between Quality and Pharmacovigilance
1 min
30 secs
What does a PSMF do?
55 secs
PSMF structure
40 secs
Required information
33 secs
Additional PSMF requirements
35 secs
Pharmacovigilance inspections
55 secs
Pharmacovigilance audits
32 secs



Test Your Knowledge


Revision History


Ian Nicholls

Director at Explic8


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