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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.

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 decisions that determine inspection readiness across the EU, the United Kingdom and Switzerland.

Related publications

Thumbnail for White Paper No. 1: Pharmacovigilance Across Multiple Marketing Authorisation Holders

Schilling Vigilance

White Paper No. 1

White Paper

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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
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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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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
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