Personal Background

Dr. Peter-Jürgen Kramer, Certified Expert in Toxicology GT/DGPT, EUROTOX Registered Toxicologist

  • Wide experience as leading toxicologist in the chemical and pharmaceutical industry (Non-Clinical Drug Safety and safety Assessment of Industrial Chemicals/Cosmetics) ,
  • Retired Head (Vice-President), Institute of Toxicology and Global Head of Toxicology and Safety Pharmacology, Merck KGaA/Merck Serono
  • Long-standing lecturer in toxicology at universities in Germany (Darmstadt and Bonn) and France (Lyon)
  • France (Lyon) member of: Formation à la direction d”études de toxicologie – Enseignement dirigé, Université Claude Bernard, Lyon 1 (1997 – 2010)
  • Conduct of seminars in the fields of preclinical development of drugs (e.g. Preclinical Drug Safety – Forum Institute, Heidelberg)
  • Member of Scientific Programme Committee and Local Organizing Committee of 46th Congress of the European Societies of Toxicology in Dresden, EUROTOX 2009 13—16 September 2009 in Dresden, Germany
  • Member of Corporate Sub-Committee of the Federation of European Toxicologists & European Societies of Toxicology (EUROTOX)
  • Vice-President of the German Society of Toxicology (GT), 2003 – 2010
  • Member of the Beratungskommission (Advisory Committee) of the German Society of Toxicology(GT)
  • Member (incl. Chairman) of Board of Trustees of Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM), Hannover, Germany, 2000 – 2009
  • Member of the Expertengremium für Chemikaliensicherheit (Expert Committee for Chemical Safety)
  • More than 2 decades official representative of Germany in expert groups of EU and OECD for the harmonisation of toxicological test methods, among others also for a drastic reduction of animal testing
  • Active involvement in the development and shaping of toxicology in Germany and Europe (Drug and Chemical Safety)
  • Repeatedly nominated as member of expert committees (juries) of the German Ministry of Education and Research (BMBF), granting of public funding for research projects in the fields of “Replacement of Animal Testing” and “Innovation in Drug Development”.

Activities 2016

  • Non-Clinical Drug Safety Consulting for pharmaceutical companies. Evaluation and interpretation of the safety of existing and potential products, metabolites, degradants, impurities and intermediates, presently major indication areas Alzheimers disease and Diabetes
  • Lecturship at the Universities of Darmstadt, Bonn and Lyon, Subjects: Toxicological Testing, Assessment of Toxicology Results, General Toxicology, Genetic Toxicology, Reproduction Toxicology
    • Darmstadt: Gefahrstoffkunde I (Toxicology) and Gefahrstoffkunde II (Legal/Regulation), compulsory lectures for students of chemistry‚ Technical University Darmstadt
    • Bonn: Master of Drug Regulatory Affairs – General Toxicology, Reproduktion Toxikologie, University Bonn und DGRA (German Society for Regulatory Affairs)
    • Lyon: Eudipharm – European Diploma in Pharmaceutical Medicine, Université Claude Bernard, Lyon 1
  • Member of the Weiterbildungskommission(Education Committee) (Formation: certified  Expert in Toxicology (GT/DGPT)
  • Member of the Editorial Board of the journal ‘Archives of Toxicology’
  • Reviewer for the Naunyn-Schmiedeberg’s Archives of Pharmacology
  • Member of US Society of Toxicology (SOT) and Drug Information Association (DIA)

Publications (Selection)

  1. Are chromosomal aberration tests in vitro particulary prone to artificial findings?, P.-J. Kramer, bga Schriften 1/1993
  2. Neurotoxicity Risk Assessment of MPTP (N-methyl-4-phenyl-1,2,3,6-tetrahydropyridine) as a Synthetic Impurity od Drugs, Kramer, P.-J.; Caldwell, J.; Hofmann, A.; Tempel, P.; Weiße, G., Human & Experimental Toxicology 17:283-293 (1998)
  3. Genetic Toxicology, Kramer, P.-J., J. Pharm. Pharmacol. 50:395-405 (1998)
  4. The polycyclic musk 7-acetyl-1,1,3,4,4,6-hexamethyl-1,2,3,4,-tetrahydronaphthaline lacks tumor initiating and promoting activity in rats exposed to human-relevant doses., P. Steinberg, I. Zschaler, E. Thom, M. Kuna, G. Wüst, A. Schäfer-Schwebel, R. Müller, P.-J. Kramer, G. Weiße, Arch. Toxicol. 75:562-568 (2001)
  5. Zur Bedeutung von genetischen Polymorphismen von Fremdstoff-metabolisierenden Enzymen in der Toxikologie. Stellungnahme der Beratungskommission der Sektion Toxikologie der Deutschen Gesellschaft für experimentelle und klinische Pharmakologie und Toxikologie (DGPT), THOMAS SCHULZ, GISELA DEGEN, HEIDI FOTH, REGINE KAHL, PETER-JÜRGEN KRAMER, WERNER LILIENBLUM, DIETER SCHRENK, HERMANN SCHWEINFURTH, Umweltmed Forsch Prax 7 (4) 7A (2002)
  6. The REACH concept and its impact on toxicological sciences., J.G. Hengstler, H. Foth, R. Kahl, P.-J. Kramer, W. Lilienblum, T. Schulz, H. Schweinfurth, Toxicology 220:232-239 (2006)
  7. Nadine Zidek, Juergen Hellmann, Peter-Juergen Kramer and Philip Hewitt, Acute Hepatotoxicity: A predictive Model based on Focused Illumina Microarrays,Toxicological Sciences 99(1): 289-302 (2007)
  8. Non-clinical Study Reports (Module 4 EU-CTD) Guide to Drug Regulatory Affairs, Klaus Olejniczak, Gerd Bode, Peter Kasper, Eckhard von Keutz, Peter-Jürgen Kramer, Editio Cantor 685-716 (2007)
  9. Hengstler JG, Foth H, Gebel T, Kramer PJ, Lilienblum W, Schweinfurth H, Völkel W, Wollin K-M, Gundert-Remy U. Critical evaluation of key evidence on the human health hazards of exposure to bisphenol A. Crit Rev Toxicol. 2011 Apr;41(4):263-91.

Back to Non-Clinical-Safety Assessment -Toxicology
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