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Publications

Books, white papers and practical insights

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.

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Primary collection

White Papers

In-depth analysis, practical frameworks and implementation guidance for pharmacovigilance, artificial intelligence and regulated organisations.

Complete white papers collection

Structured guidance for regulated pharmacovigilance practice

The dedicated White Papers page is built for a growing library, with topic filters, quick search and clear links into each publication detail page.

Thumbnail for White Paper No. 6: Beyond “Human in the Loop”

Schilling Vigilance

White Paper No. 6

White Paper

Published

Beyond “Human in the Loop”

Designing Effective Human Oversight in Pharmacovigilance AI

Designing Effective Human Oversight in Pharmacovigilance AI

  • Artificial Intelligence
  • Human Oversight
  • Pharmacovigilance
Publication information
English
Publication information
25 September 2026
Publication information
Rev. 0
Thumbnail for White Paper No. 7: Changing the Engine While Flying

Schilling Vigilance

White Paper No. 7

White Paper

Published

Changing the Engine While Flying

Maintaining the Validated State When AI Models Change in Pharmaceutical GxP Systems.

Maintaining the Validated State When AI Models Change in Pharmaceutical GxP Systems.

  • Artificial Intelligence
  • GxP
  • Validation
Publication information
English
Publication information
25 September 2026
Publication information
Rev. 0
Thumbnail for White Paper No. 8: Qualifying AI-Enabled Pharmacovigilance Service Providers

Schilling Vigilance

White Paper No. 8

White Paper

Published

Qualifying AI-Enabled Pharmacovigilance Service Providers

A Practical Due-Diligence and Oversight Framework.

A Practical Due-Diligence and Oversight Framework.

  • Artificial Intelligence
  • Due Diligence
  • Pharmacovigilance
Publication information
English
Publication information
25 September 2026
Publication information
Rev. 0
Thumbnail for White Paper No. 5: Controlled Digital Intake

Schilling Vigilance

White Paper No. 5

White Paper

Published

Controlled Digital Intake

From social-media message to controlled action using n8n and bounded AI.

From social-media message to controlled action using n8n and bounded AI.

  • Artificial Intelligence
  • Pharmacovigilance
  • Digital Intake
Publication information
German
Publication information
24 September 2026
Publication information
Rev. 0
Thumbnail for White Paper No. 1: Pharmacovigilance Across Multiple Marketing Authorisation Holders

Schilling Vigilance

White Paper No. 1

White Paper

Published

Pharmacovigilance Across Multiple Marketing Authorisation Holders

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.

  • Pharmacovigilance
  • Governance
  • Inspection Readiness
Publication information
German
Publication information
September 2026
Publication information
Rev. 0
Thumbnail for White Paper No. 2: The AI-Enabled PSMF

Schilling Vigilance

White Paper No. 2

White Paper

Published

The AI-Enabled PSMF

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.

  • Artificial Intelligence
  • PSMF
  • Pharmacovigilance
Publication information
German
Publication information
September 2026
Publication information
Rev. 0
Thumbnail for White Paper No. 3: EU PSMF and UK PSMF

Schilling Vigilance

White Paper No. 3

White Paper

Published

EU PSMF and UK PSMF

What start-ups really need to do.

What start-ups really need to do.

  • PSMF
  • Regulatory Compliance
  • Pharmacovigilance
Publication information
German
Publication information
September 2026
Publication information
Rev. 0
Thumbnail for White Paper No. 4: Pharmacovigilance in a Multi-Entity Marketing Authorisation Structure

Schilling Vigilance

White Paper No. 4

White Paper

Published

Pharmacovigilance in a Multi-Entity Marketing Authorisation Structure

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.

  • Pharmacovigilance
  • Governance
  • Inspection Readiness
Publication information
German
Publication information
September 2026
Publication information
Rev. 0

Publications and books

Publications & Books

Peer-reviewed publications, professional articles and books covering pharmacovigilance, leadership, governance and the responsible use of artificial intelligence.

Publications

  1. 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

Books

Book

In preparation

Leadership in the Age of AI

A practical exploration of leadership, accountability and decision-making in working environments increasingly supported by artificial intelligence.

  • Leadership responsibility
  • Human judgement
  • Decision-making with AI support
Publication information
German

Book

In preparation

From Science to the Office

A practical guide for scientists moving from university, research or laboratory environments into professional organisational life.

  • Career transition
  • Applications and interviews
  • The first months in an organisation
Publication information
German

Book

In preparation

Practical Pharmacovigilance: From Case Intake to Benefit-Risk Judgement

A structured introduction connecting scientific foundations, regulatory requirements and practical insights from global drug safety operations.

  • Pharmacovigilance foundations
  • Regulatory responsibilities
  • Global safety systems

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

Conference Contributions

Selected conference contributions and professional forum appearances will be listed here when publication details are confirmed.

No conference contributions are currently listed.

Slides and presentation materials

Presentations

Presentation materials and slide-based publications will be added here when they are available for public access.

No presentations are currently listed.