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

Welcome

Course Introduction

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

Documentation

20 secs

Relationship between Quality and Pharmacovigilance

1 min

Activity

30 secs

Pharmacovigilance system master file (PSMF)

What does a PSMF do?

55 secs

PSMF structure

40 secs

Required information

33 secs

Additional PSMF requirements

35 secs

Inspections and Audits

Pharmacovigilance inspections

55 secs

Pharmacovigilance audits

32 secs

Conclusion

Summary

Test Your Knowledge

Results

Revision History

Author

Ian Nicholls

Director at Explic8

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