A Guide to the Pharmacovigilance Manager (QPPV) and His Team
A Guide to the Pharmacovigilance Manager (QPPV) and His Team
Pharmacovigilance is one of the most sensitive and highly regulated areas of the pharmaceutical industry.
This operational guide walks you through the requirements of the Good Pharmacovigilance Practices (GVP Modules I–XV), with a practical approach to help you effectively manage documents, procedures, and inspections.
What you’ll find inside:
👁️ Clear summary of the GVPs: operational explanations of the main modules
🧾 PSUR and RMP: how to prepare and maintain them in compliance
✅ Audit checklists: tools to face GVP inspections with confidence
🚀 Common errors: the most critical findings reported by inspectors
A manual designed for Pharmacovigilance, Regulatory Affairs, and QA professionals who must ensure compliance without getting lost in complex documentation.
Each section includes real examples, diagrams, and practical boxes, making the guide immediately usable in daily operations.
Format: Professional PDF
Length: 85 operational pages
Updated: December 2025 – includes references to the latest EMA and AIFA guidelines
Available languages: ITA – ENG
DOWNLOAD A PREVIEW OF THE GUIDE
Couldn't load pickup availability
HAVE QUESTIONS? CHECK OUT OUR FAQS
What will I find in this guide?
In addition to operational explanations of the relevant regulations, you will find checklists, templates, real-life cases, and common mistakes to avoid.
How up-to-date is the guide?
The guide includes updated references to the latest EMA and EU GMP regulations, as well as guidance from all international inspection bodies. In the event of future revisions, we expect updates to be made available to buyers.
How long is it and how long does it take to read?
Each guide has a specific length based on the complexity of the topic, but they are all designed for quick reference. You can use it as a daily reference manual.
Who is this guide most useful to?
Junior professionals → to learn quickly and reduce errors.
Senior professionals → to have ready-to-use checklists and templates to share with the team.
Can I download it multiple times or share it?
Once purchased, you can download and keep it. It is for personal or internal business use only, but external redistribution is not permitted.