Pharmacovigilance – Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

1 minute read Uncategorized

Updated on August 15, 2024

Updated on August 15, 2024

USFDA Guidance for Industry: E2E Pharmacovigilance Planning
USFDA: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
USFDA Presentation: An Overview of Pharmacovigilance in the Center for Drug Evaluation and Research (PDF – 2MB)
Europe (EMA): Pharmacovigilance system: Questions and Answers
European Medicines Agency: Good pharmacovigilance practices
Europe (EMA): Guideline on good pharmacovigilance practices (GVP) Module II – Pharmacovigilance system master file (Rev 2)
Europe (EMA): Guideline on good pharmacovigilance practices (GVP) Module I – Pharmacovigilance systems and their quality systems
ICH Pharmacovigilance (E2A-E2F); ICH E2E Pharmacovigilance planning (Pvp) – Scientific guideline
Pharmacovigilance Programme of India (PvPI); ADR Reporting Form
MHRA: Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF)
MHRA: Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK MAHs and the MHRA
MHRA: Guidance updates on to how to notify the MHRA of changes to the PV System

Share: