Good Pharmacovigilance Practices (GVP)

Good Pharmacovigilance Practices (GVP): Updates to the European Union GVP Guidelines

This course will provide a robust introduction to all modules of GVP, enabling you to understand the impact of the GVP modules throughout the pharmacovigilance landscape.

This course will also review pharmacovigilance legislation changes over the years. If you are involved in drug safety, pharmacovigilance, regulatory, or quality compliance, this training will help you keep up to date on GVP guidelines.

CEU Credits: .1
Course Code: ELM-922
Duration: 30 mins
Skill Level: Basic
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.1
Effective Date: 07/11/2022

Curriculum for this course

Course Overview
What You'll Learn
EU GVP Update Process
General Principles of Post-Brexit UK Pharmacovigilance

Knowledge Check

Module l
Module ll
Module lll
Module lV
Module V
Module Vl
Module Vl - Addendum l
Module Vll
Module Vlll
Module Vlll - Addendum l
Module Xl
Module Xl - Addendum 1
Module X
Module XV
Module XVl
Module XVl - Addendum l
Updates to Chapters On Product-Or Population-Specific Considerations
Product-or Population-Specific Considerations I – Vaccines for Prophylaxis Against Infectious Diseases
Product-or Population-Specific Considerations II – Biological Medicinal Products
Product-or Population-Specific Considerations IV – Pediatric Population
Final GVP Annexure Updates
GVP Annex I
GVP Annex II - Templates
Final GVP Annexure Additions
GVP Annex III – Other Pharmacovigilance Guidance
Note For Guidance – Eudravigilance Human – Processing Of Safety Messages And Individual Case Safety Reports (ICSRS)
GVP Annex IV
GVP Annex V

Final GVP Annexure Updates and Additions Quick Knowledge Check

What We Covered
Test Your Knowledge
Results
Minor update: Update to v1.1 to fix typo and add "Select all that apply" to multiple select questions
V1.1

Author

Joginder Mittal

Manager - Quality Compliance Glatt Pharma Engineering

Courses

Browse our extensive catalog of GxP, Corporate Compliance and EH&S training.

Learning Strategy

Boost your organization’s training with LearnGxP’s Learning Strategy Consultants (LSC). They customize learning paths to match your needs, offering ongoing support for lasting success.

Customer Stories

Discover how LearnGxP addresses real challenges, provides effective solutions, and positively impacts our customers’ organizations.