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Reinhold Schilling speaking at a conference

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Speaker kit

Everything needed to announce a talk: bios in English and German, a portrait and a stage photo, talk topics and recent conference contributions.

Portrait 1122 × 1402 px · Stage photo 1136 × 1385 px · WebP

Bios

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Short bio · English

Reinhold Schilling is Head of Global Pharmacovigilance at an internationally operating pharmaceutical group, EU Qualified Person for Pharmacovigilance (EU QPPV) and Stufenplanbeauftragter. He has worked in pharmacovigilance and regulatory affairs since 2011, teaches pharmacovigilance at Goethe Business School and Reutlingen University, and speaks on pharmacovigilance governance and the responsible use of artificial intelligence.

53 words

Long bio · English

Reinhold Schilling is Head of Global Pharmacovigilance at an internationally operating pharmaceutical group, where he serves as EU Qualified Person for Pharmacovigilance (EU QPPV) and Stufenplanbeauftragter. He holds a Diplom in Chemistry from the University of Bonn and a Master of Drug Regulatory Affairs, and has worked in pharmacovigilance and regulatory affairs since 2011. He teaches pharmacovigilance at Goethe Business School and Reutlingen University and is a member of the Pharmacovigilance Committee of BPI e.V. His conference contributions focus on pharmacovigilance governance and on human-in-the-loop use of artificial intelligence in case processing. He is the author of Practical Pharmacovigilance: From Case Intake to Benefit–Risk Judgement and Die Pharmaindustrie: Rollen, Übergaben und Entscheidungen verstehen, and of the Schilling Vigilance white paper series. He speaks in English and German.

127 words

Kurzbiografie · Deutsch

Reinhold Schilling ist Head of Global Pharmacovigilance in einer international tätigen Pharmagruppe, EU Qualified Person for Pharmacovigilance (EU QPPV) und Stufenplanbeauftragter. Er arbeitet seit 2011 in Pharmakovigilanz und Regulatory Affairs, lehrt Pharmakovigilanz an der Goethe Business School und der Hochschule Reutlingen und spricht über Governance in der Pharmakovigilanz und den verantwortungsvollen Einsatz künstlicher Intelligenz.

54 Wörter

Talk topics

What Reinhold speaks about

01

PV foundations and governance

Build a shared understanding of the systems, roles and evidence that support accountable oversight.

  • Pharmacovigilance foundations
  • Global pharmacovigilance systems
  • EU QPPV responsibilities and PV governance
  • Pharmacovigilance System Master File

02

Scientific and regulatory responsibilities

Connect regulatory expectations with the scientific reasoning behind safety decisions.

  • GVP and regulatory requirements
  • Signal management
  • Risk management
  • Benefit-risk evaluation

03

Operations, quality and oversight

Examine how robust operations, interfaces and evidence sustain inspection-ready systems.

  • Inspection and audit readiness
  • Literature monitoring
  • Safety data and case management
  • Interfaces with Quality and Regulatory Affairs

04

Leadership and emerging practice

Explore accountable leadership and technology use where judgement remains essential.

  • Artificial intelligence in pharmacovigilance
  • Leadership in regulated organisations
  • Governance under operational pressure
  • Decision-making and accountability

Track record

Recent conference contributions

  1. 18 September 2026

    17th International SLS Days

    GxP / AI Governance: From interesting tools to controlled processes

    Hannover, Germany

  2. 29 April 2026

    5th Pharmacovigilance & Drug Safety Conference

    Human-in-the-Loop AI for Pharmacovigilance Case Intake: From Raw Emails to Validated E2B(R3) with Measurable QC Time Savings

    Madrid, Spain

  3. 24 February 2026

    European Drug Safety & AI 2026

    Human-in-the-Loop AI for Pharmacovigilance Case Intake: From Raw Emails to Validated E2B(R3) with Measurable QC Time Savings

    Barcelona, Spain

  4. November 2025

    World Drug Safety Congress Americas

    AI in Case Management: Limits and Opportunities

    Boston, Massachusetts, USA

  5. 7–8 October 2025

    World Drug Safety Congress Europe

    AI in Case Management: Limits and Opportunities

    Amsterdam, Netherlands

  6. 2025

    Chem-Academy Conference

    How a Small Company Revolutionized Its Case Intake with theralyze.ai: AI-Powered E2B(R3) Generation for Safety Databases with Human QC, Saving Time and Reducing Manual Effort

Seminars and invited contributions

  • 2026 — FORUM Institut für Management · The EU Qualified Person for Pharmacovigilance (EU QPPV) · two-day seminar, English, with Dr Tanja Peters
  • 2026 — Online Pharma FORUM · Human-in-the-loop AI in pharmacovigilance · invited talk
  • 2026 — European Drug Safety & AI, Barcelona · conference speaker
  • 2025 — FORUM Institut für Management · SOPs in der Pharmakovigilanz · one-day seminar, sole speaker
  • 2025 — FORUM Institut für Management · Expert-FORUM: Drug Safety in der digitalen Welt · webcast series, including an AI case study on ICSR processing
  • 2025 — Chem Academy · AI applications in pharmacovigilance: legal framework and recommendations · conference presentation
  • 2024 — Chem Academy · Information management in pharmacovigilance and workshop on data science and AI · conference contribution

Practical details

Languages
English and German
Delivery
Online and on-site
Location
International delivery
Design
Content, examples and format agreed individually

Planning an event?

Share the audience, topic, date and format, and Reinhold will reply by email.