Prof. Dr. Johannes Harleman, Fresenius Kabi Deutschland GmbH - Qepler Summits And Conferences

Prof. Dr. Johannes Harleman

Vice-President Global Preclinical Development & Management
Fresenius Kabi Deutschland GmbH
Bad Homburg vor der Höhe, Germany

Hans is an experienced Preclinical Safety expert. He graduated in veterinary medicine in 1978 in Utrecht, the Netherlands.

He did his PhD studies at the University of Illinois at Urbana Champaign, department of veterinary pathobiology. He worked as a pathologist and manager for several pharmaceutical companies in Switzerland, United Kingdom and Germany (Ciba-Geigy, Smith Kline & French, ASTA Medica/Degussa, Novartis, Merck, Astra Zeneca).

He worked as an independent toxicology and pathology consultant in 2013- 2014.

Currently he is Vice President Global Preclinical Development and Management at Fresenius-Kabi in Bad Homburg Germany.

In February 2004 he became honorary professor at the Tieraertzliche Hochschule in Hannover.

He contributed to many successful registrations of both NBEs, NCEs and chemicals. He has ca 50 publications in peer reviewed journals or contributions to book chapters.

Short version: Hans graduated in veterinary medicine in 1978 in Utrecht, the Netherlands. He did his PhD studies at the University of Illinois at Urbana Champaign, department of veterinary pathobiology.

He worked as a pathologist and preclinical safety manager for several pharmaceutical companies in Switzerland, United Kingdom and Germany.

Currently he is Vice President Global Preclinical Development and Management at Fresenius-Kabi in Bad Homburg Germany.

Related Sessions:

Genotoxic Impurities in
Pharmaceuticals Summit 2019

GTI strategies & new methodologies: analysis, in silico & regulations. Challenges & opportunities.
  • 11 Apr 2019
  • Berlin, DE
  • Pharma
Day 1: Thursday, 11 April 2019
BLOCK:
CASE STUDY: Strategies for assessment of impurities and E&Ls.
  • Definitions of E&L and impurities
  • Qualification thresholds
  • Use of QSAR
  • Role of API in assessment
  • Experience with regulators on PQRI proposals
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