New · First edition, 2026
Practical Pharmacovigilance
From Case Intake to Benefit–Risk Judgement
Reinhold Schilling
A practitioner's guide to EU pharmacovigilance systems, from the first adverse event report to the decision a company has to defend in front of an inspector.
PDF · DIN A4 · 431 pages · instant download · secure payment via Digistore24
“This book is excellent! It feels like a comprehensive pharmacovigilance course, with clear explanations and practical examples. I learned so much and found answers to questions that come up in my daily work.”
Natalka IshchukPharmacovigilance systems expertWhat the book covers
Most pharmacovigilance books explain the rules. This one shows how the work gets done. It follows the EU system as it stands in September 2026: GVP, EudraVigilance and EVDAS, Implementing Regulation (EU) 2025/1466, ICH E2B(R3) and E2D(R1).
- Case processing and ICSRs
- Signal management
- PSURs and PSUSA
- Risk management plans
- QPPV and PSMF
- Vendor oversight
- Inspections and CAPA
- Clinical trial safety
- Biosimilars, ATMPs and vaccines
- PV economics and governance
Two reading paths
Trainee path
For the people who do the work: definitions, process logic, first-line handling.
Executive path
For the people accountable for it: licence to operate, inspection exposure, resourcing.
Both
Where the two meet. This is where most real failures happen.
In the book, coloured bars at the page edges show which path each section belongs to.
Inside
- 431 pages
- 97 figures
- Quizzes with explained answers
- Templates and full index
About the author
Reinhold Schilling is Head of Global Pharmacovigilance and EU-QPPV at an international pharmaceutical company. He also works independently as a lecturer and trainer, and teaches pharmacovigilance at Goethe Business School (Pharma MBA) and Hochschule Reutlingen. He started in industry in 2011 as a Drug Safety Junior Manager. He holds a Diplom in chemistry and an M.D.R.A. from the University of Bonn.
Questions
Which format do I get?
A PDF in DIN A4 with all 97 figures and the reading-path bars in colour. It works on any computer or tablet, and individual chapters print cleanly on A4 paper.
How do I receive it?
Right after payment you get a download link by email from Digistore24, who handles payment and invoicing.
Can my team use one copy?
The PDF is licensed for personal use. For team or company licences, write to [email protected].
Is there a printed edition?
Yes, as a paperback on Amazon, where a Kindle edition is also available.
I am a student in one of Reinhold's courses.
You receive the book free of charge through your course. You do not need to buy it here.
Is this legal or regulatory advice?
No. The book is for education and training. It is not legal, regulatory or medical advice.
Practical Pharmacovigilance – PDF eBook, 39 €