1 1

A Guide to the Pharmacovigilance Manager (QPPV) and His Team

A Guide to the Pharmacovigilance Manager (QPPV) and His Team

€149,00 EUR
€149,00 EUR
Sale Sold out
Taxes included. Digital product – immediate access after payment.
Digital productImmediate access after payment
Secure paymentDigital download, no shipping

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

Preview ITA

Preview ENG
Versione in lingua

View full details

DECLARED REGULATORY BASIS

Built on the most up-to-date official sources.

Every guide is built from the official sources current at the editorial verification date stated in the document. The editions, revisions and cut-off dates used are declared and checked again for every new release; requirements are kept distinct from GuideGxP operational interpretation.

Main references for this guide EU GVP Modules · Regulation (EC) No 726/2004 · Directive 2001/83/EC
  • Editions and revisions stated in the document
  • Explicit editorial verification date
  • Requirements separated from practical recommendations

GuideGxP is an independent publisher and is not affiliated with, approved by or sponsored by the authorities and organisations cited.

INCLUDED WITH YOUR PURCHASE

Every new release is delivered automatically by email.

Buy once: whenever we publish a new release of the guide you purchased, it is sent automatically to the email address used for the order, together with the download link. No request, new registration or additional payment is required.

  • Every future release included for life
  • Automatic delivery to the order email
  • Average review cycle: 6 months

Timing may vary with regulatory and technical developments. No action is required after purchase; simply use a valid email address at checkout.

FREQUENTLY ASKED QUESTIONS

Everything you need to know before purchasing.

Clear information about downloads, formats, languages and the use of GuideGxP resources.

Immediate access No shipping Secure payment
Do you have a specific question about this product? Contact GuideGxP
How will I receive the digital product?

After payment is confirmed, instructions for accessing the digital download are made available through the order confirmation process. Use a correct email address during checkout.

Will a physical product be shipped?

No. GuideGxP resources are digital products, with no printed materials, shipping costs or physical delivery times.

In which language will I receive the content?

Available languages are shown on the product page. When multiple versions are offered, select the required language before completing your purchase.

Are the files editable?

Guides are generally supplied as PDF files. Word or Excel templates and other editable tools are included only when expressly stated in the product description.

Can I view a preview before purchasing?

When available, you can open the preview free of charge using the buttons on the product page to review its structure, level of detail and operational approach.

What should I do if I need assistance?

Contact GuideGxP with the product name and your question. We will help you confirm the language, format and suitability of the resource for your needs.