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.

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CEU Credits: 0.1
Course Code: ELM-939
Duration: 15 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.1
Effective Date: 05/01/2024

Curriculum for this course

Welcome

Pharmacovigilance systems
Setting up a quality system for pharmacovigilance
Quality cycle and objectives
Additional groups
Record management
Documentation
Relationship between Quality and Pharmacovigilance
Activity
What does a PSMF do?
PSMF structure
Required information
Additional PSMF requirements
Pharmacovigilance inspections
Pharmacovigilance audits

Conclusion

Summary

Test Your Knowledge

Results

Minor update: Content added to provide more detailed information on inspections and audits, QPPV and sources of safety data, and annexes, change control, versioning, and archiving.
V1.1

Author

Ian Nicholls

Director at Explic8

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