Reinhold Schilling | Schilling Vigilance
Global Pharmacovigilance Leader · EU QPPV · Speaker · Lecturer
Pharmacovigilance that holds up under inspection.
EU QPPV, Stufenplanbeauftragter and Head of Global Pharmacovigilance. Keynotes, training and university teaching on pharmacovigilance systems, inspection readiness and responsible AI, for pharmaceutical teams, conference organisers and academic programmes.
Or email [email protected]Explore the books
- EU QPPV
- Stufenplanbeauftragter
- Head of Global Pharmacovigilance since 2021
- In pharmacovigilance since 2011
- Lecturer · Goethe Business School · Reutlingen University
- Member, Pharmacovigilance Committee of BPI e.V.
Recent work
Training, talks, papers and books
Training course
19–21 October 2026
Artificial Intelligence in Pharmacovigilance: From use cases to inspection-ready governance, validation and human oversight
Fleming · Three-day online live training, with Julia Appelskog
Conference talk
18 September 2026
GxP / AI Governance: From interesting tools to controlled processes
17th International SLS Days · Hannover, Germany
White Paper No. 13
1 October 2026
Inspection-Ready AI in Pharmacovigilance
Governance, lifecycle assurance and transaction-level traceability
Book
October 2026
Die Pharmaindustrie: Rollen, Übergaben und Entscheidungen verstehen
Für Einsteiger, Quereinsteiger und Wiedereinsteiger in der Pharmaindustrie.
Peer-reviewed article
pharma industrie · 2027
Pharmakovigilanz ist Chefsache: Warum Arzneimittelsicherheit eine Führungsaufgabe ist und welche Fragen das Management stellen muss
Schilling R, Siefer S, Brüning S.
Ways to work together
Speaking and training formats
Keynotes
Conference and congress contributions on drug safety, leadership and responsible AI.
Request a keynoteExecutive Workshops
Working sessions with leadership teams on safety governance and decision-making.
Discuss a workshopRegulatory Training
Structured training on pharmacovigilance obligations, QPPV responsibilities and inspection readiness.
Discuss a trainingAcademic Teaching
University and executive education connecting regulatory science with practical safety work.
Discuss teaching
Professional exchange on pharmacovigilance governance, regulatory accountability, leadership and the responsible use of artificial intelligence is also welcome.
Start a professional exchangeArtificial intelligence & drug safety
Responsible AI for structured pharmacovigilance case processing.
AI can support the process. Qualified experts remain accountable.
A human-in-the-loop framework for AI-supported case intake and E2B(R3) data structuring, with defined expert oversight, validation evidence and a documented audit trail. Built around the questions an inspector actually asks: who decided, on what basis, and where is it written down?
Every case tells a story – behind it is a patient.
- 1
AI-supported case intake
- 2
AI-supported E2B(R3) data structuring
- 3
Expert quality control
- 4
Governance and validation
Human in the loop: qualified experts remain accountable
Books
Practical books on pharmacovigilance and the pharmaceutical industry
English · PDF, 431 pages
Practical Pharmacovigilance
From Case Intake to Benefit–Risk Judgement
For the people who do pharmacovigilance work and the people accountable for it.
97 figures · quizzes with explained answers · templates
“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 expert39 €
Deutsch · PDF, 394 Seiten
Die Pharmaindustrie
Rollen, Übergaben und Entscheidungen verstehen
Für Einsteiger, Quereinsteiger und Wiedereinsteiger in der Pharmaindustrie.
22 Abbildungen · über 160 Glossarbegriffe · Merksätze
19,99 €
Perspectives on safety, technology and leadership
Current publications and book projects address pharmacovigilance, leadership in regulated organisations and the responsible use of artificial intelligence.
- Leadership in the Age of AI (in development, German)
- From Science to the Office (in development, German)
Free tools
Practical resources for pharmacovigilance teams
Version 1.9.4 · Free
Literature Search Tool
A prototype for pharmacovigilance literature review, running in your browser.
Open tool
Database v6.4 · Draft research, not yet verified
PV Country Knowledge
Pharmacovigilance requirements by country on an interactive world map, each finding traced to its legal or authority source. Findings are drafts from AI-assisted research and are labelled with their review status.
Open tool
Version 1.0 · 10 topics, 300 questions
EU Pharmacovigilance Quiz
Self-assessment on EU pharmacovigilance, from the legal framework to inspections. Every answer is explained and referenced, and passing a topic gives a certificate of completion.
Open tool
Version 1.0 · Escape room · 45–75 minutes
The GxP Validation Chaos
An escape room for pharmacovigilance professionals. The inspectors are coming, the AI intake system is not ready: find the evidence across five rooms, connect the clues and decide what you can honestly show. Fictional scenario, for training only.
Open tool
The tools are not validated and are provided for display and testing only.
Higher education
Connecting regulatory science with practical reality
Reinhold teaches pharmacovigilance and regulatory affairs at Goethe Business School (Goethe University Frankfurt) and Reutlingen University, combining a scientific foundation with the perspective of global pharmacovigilance responsibility.
Profile
Grounding leadership in science and practice
Reinhold Schilling is an experienced pharmacovigilance leader, EU Qualified Person for Pharmacovigilance and Stufenplanbeauftragter. His professional background combines a German university degree in chemistry from the University of Bonn with a Master of Drug Regulatory Affairs and more than fifteen years of experience in pharmacovigilance and regulatory affairs.
Professional exchange
Speaking. Training. Teaching. Professional exchange.
Enquiries from pharmaceutical organisations, conference organisers, professional associations and academic institutions are welcome.
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