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Reinhold SchillingSchilling Vigilance
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.

By Reinhold Schilling

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

Five governance decisions that determine inspection readiness in the EU/EEA, the United Kingdom and Switzerland.

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Thumbnail for White Paper No. 4: Pharmacovigilance in a Multi-Entity Marketing Authorisation Structure

Schilling Vigilance

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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
View publicationDownload PDF
Thumbnail for White Paper No. 13: Inspection-Ready AI in Pharmacovigilance

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Governance, lifecycle assurance and transaction-level traceability

Governance, lifecycle assurance and transaction-level traceability

  • Artificial Intelligence
  • Inspection Readiness
  • GxP
Publication information
English
Publication information
1 October 2026
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Article

Forthcoming

Peer-reviewed

Pharmakovigilanz ist Chefsache: Warum Arzneimittelsicherheit eine Führungsaufgabe ist und welche Fragen das Management stellen muss

Reinhold Schilling, Simone Siefer, Stefan Brüning

A peer-reviewed article on why pharmacovigilance is a leadership responsibility and the key questions management must address on drug safety.

  • Pharmacovigilance
  • Governance
  • Compliance
Publication information
German

Schilling, R., Siefer, S. & Brüning, S. (2027). Pharmakovigilanz ist Chefsache: Warum Arzneimittelsicherheit eine Führungsaufgabe ist und welche Fragen das Management stellen muss. pharma industrie, 89(1), 2-9

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