Qualifications

I have studied humane medicine in Münster (Germany) and Montpellier (France) and am a licensed Doctor of Medicine.
I specialized in Pharmacology and Toxicology / Clinical Pharmacology. After having passed an extended PhD in Pharmacology and Toxicology, I was appointed as professor at the university of Münster. Up to now I give regular lectures there.
My research work during university time was centred on Endocrinology, Development Pharmacology and toxicologic evaluation of chemicals.

Experience in the pharmaceutical industry

I was the director of the Clinical Pharmacology Research Institute at Beecham and at SmithKline Beecham in Neuss (Germany). My work focussed on Phase I clinical trials (first-in-man; pharmacodynamics, pharmacokinetics, drug interactions) / analytics / statistics / data management / QC and QA. I was a member of several Drug Development Teams and participated in the creation of development plans. One of my responsibilities was to keep regular contact with the French and Italian branches of the Research Department of the company in order to collaborate in the identification of product candidates.

Experience in Contract Research

I have been directing the section of Clinical Pharmacology of Focus Drug Development for several years. In addition to Phase I clinical trials I gained experience in planning, executing and evaluating controlled clinical trials in patients.

Consultant Experience

For over 10 years I have been working as an expert and consultant.
My activities centre on the creation of Expert Reports (initially NTA, since 2000 CTD modules 2.4, 2.5, 2.6 and 2.7) as well as the creation of the accompanying documentation (modules 4 and 5).
Within the scope of the registration process I have gained experience in the handling of deficiency letters.
I am a member of the drug development teams of different companies and take part in the early / advanced development of active ingredients, essentially under strategic regulatory aspects.
This requires, for example, preparation of applications for the obtaining of Scientific Advice in single European countries or at the EMEA, the participation in the consultation, presentation and conclusion of the results.
For the preparation of clinical trials I have successfully created Investigator's Brochures (IMPD according to ICH-GCP). I have also developed recommendations for the responsible physician (guidance for the investigator) based on pharmacological - toxicological findings and, where possible, existing trials on healthy volunteers or patients.

More information about my experience and qualifications can be found in my Curriculum Vitae, der Publications list und Oral Presentations and Posters list und der Memberships in Scientific Associations page.