Publications
Reinhold Schilling publishes books, white papers and practical guidance on pharmacovigilance, leadership, responsible artificial intelligence and professional development in regulated organisations. His publications combine structured analysis with operational experience and practical tools.
Explore publicationsPrimary collection
In-depth analysis, practical frameworks and implementation guidance for pharmacovigilance, artificial intelligence and regulated organisations.
Complete white papers collection
The dedicated White Papers page is built for a growing library, with topic filters, quick search and clear links into each publication detail page.
12 white papers listed
View complete White Papers collection
Schilling Vigilance
White Paper No. 13
White Paper
Published
Governance, lifecycle assurance and transaction-level traceability
Governance, lifecycle assurance and transaction-level traceability
Schilling Vigilance
White Paper No. 12
White Paper
Published
From Disproportionality Screening to Human-Governed, AI-Augmented Signal Management
From Disproportionality Screening to Human-Governed, AI-Augmented Signal Management
Schilling Vigilance
White Paper No. 10
White Paper
Published
A Stage-Gated Implementation Model for Pharmacovigilance.
A Stage-Gated Implementation Model for Pharmacovigilance.
Schilling Vigilance
White Paper No. 9
White Paper
Published
Managing the Interfaces Between Pharmacovigilance, Product Complaints and Medical Information.
Managing the Interfaces Between Pharmacovigilance, Product Complaints and Medical Information.
Schilling Vigilance
White Paper No. 8
White Paper
Published
A Practical Due-Diligence and Oversight Framework.
A Practical Due-Diligence and Oversight Framework.
Schilling Vigilance
White Paper No. 7
White Paper
Published
Maintaining the Validated State When AI Models Change in Pharmaceutical GxP Systems.
Maintaining the Validated State When AI Models Change in Pharmaceutical GxP Systems.
Schilling Vigilance
White Paper No. 6
White Paper
Published
Designing Effective Human Oversight in Pharmacovigilance AI
Designing Effective Human Oversight in Pharmacovigilance AI
Schilling Vigilance
White Paper No. 5
White Paper
Published
From social-media message to controlled action using n8n and bounded AI.
From social-media message to controlled action using n8n and bounded AI.
Schilling Vigilance
White Paper No. 4
White Paper
Published
Five decisions that determine inspection readiness across the EU, the United Kingdom and Switzerland.
Five decisions that determine inspection readiness across the EU, the United Kingdom and Switzerland.
Schilling Vigilance
White Paper No. 3
White Paper
Published
What start-ups really need to do.
What start-ups really need to do.
Schilling Vigilance
White Paper No. 2
White Paper
Published
From Periodic Document Maintenance to a Controlled Digital Representation of the Pharmacovigilance System.
From Periodic Document Maintenance to a Controlled Digital Representation of the Pharmacovigilance System.
Schilling Vigilance
White Paper No. 1
White Paper
Published
Five governance decisions that determine inspection readiness in the EU/EEA, the United Kingdom and Switzerland.
Five governance decisions that determine inspection readiness in the EU/EEA, the United Kingdom and Switzerland.
Publications and books
Peer-reviewed publications, professional articles and books covering pharmacovigilance, leadership, governance and the responsible use of artificial intelligence.
2027
Schilling R, Siefer S, Brüning S.
Pharmakovigilanz ist Chefsache: Warum Arzneimittelsicherheit eine Führungsaufgabe ist und welche Fragen das Management stellen muss.
pharma industrie. 2027;89(1):2–9.
Peer-reviewed journal publication
Book
Published
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.
Book
Published
Rollen, Übergaben und Entscheidungen verstehen
Dieses Buch folgt einem Arzneimittel durch neunzehn Funktionen und zeigt in jedem Kapitel, wer welches Wissen hat, wer es bewertet, wer entscheidet und was bei der Übergabe verloren gehen kann.
Book
Leadership in the Age of AI
Book
In preparation
A practical exploration of leadership, accountability and decision-making in working environments increasingly supported by artificial intelligence.
Book
From Science to the Office
Book
In preparation
A practical guide for scientists moving from university, research or laboratory environments into professional organisational life.
Titles shown on this page are working titles unless explicitly identified as final. Publication formats, dates and availability will be added after confirmation.
Events and professional forums
Selected conference contributions and professional forum appearances will be listed here when publication details are confirmed.
View conference contributions 2025–2026