Lebanese Guideline On Good Pharmacovigilance Practices (LGVP)

Introduction

Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with release of Addendum III of Module XVI on pregnancy prevention programmes for public consultation

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EMA/95595/2022 example

GVP modules

Guideline on good pharmacovigilance practices (GVP): Module I – Pharmacovigilance systems and their quality systems

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Guideline on good pharmacovigilance practices (GVP): Module II – Pharmacovigilance system master file

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Guideline on good pharmacovigilance practices (GVP): Module III – Pharmacovigilance inspections (Rev 1)

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Guideline on good pharmacovigilance practices (GVP): Module IV – Pharmacovigilance audits (Rev 1)

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Guideline on good pharmacovigilance practices (GVP): Module V – Risk management systems (Rev 2)

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Guideline on good pharmacovigilance practices (GVP): Module VI – Collection, management and submission of reports of suspected adverse reactions to medicinal products (Rev 2)

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Guideline on good pharmacovigilance practices (GVP): Module VI Addendum I – Duplicate management of suspected adverse reaction reports

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Guideline on good pharmacovigilance practices (GVP): Module VII – Periodic safety update report (Rev 1)

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Guideline on good pharmacovigilance practices (GVP): Module VIII – Post-authorisation safety studies (Rev 3)

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Guideline on good pharmacovigilance practices (GVP): Module VIII Addendum I – Requirements and recommendations for the submission of information on non-interventional post-authorisation safety studies (Rev 3)

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Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev 1)

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Guideline on good pharmacovigilance practices (GVP): Module IX Addendum I – Methodological aspects of signal detection from spontaneous reports of suspected adverse reactions

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Guideline on good pharmacovigilance practices (GVP): Module X – Additional monitoring
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Guideline on good pharmacovigilance practices (GVP): Module XV – Safety communication (Rev 1)

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Guideline on good pharmacovigilance practices (GVP): Module XVI – Risk minimisation measures: selection of tools and effectiveness indicators (Rev 2

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Guideline on good pharmacovigilance practices (GVP): Module XVI Addendum I – Educational materials

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