Qualifications

 

I have studied human 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.

My research work during university time was centred around Endocrinology, Developmental Pharmacology and toxicologic evaluation of chemicals.

Experience in the pharmaceutical industry

I started my industry carreer as head of the Clinical Pharmacology Research Institute of Beecham, later SmithKline Beecham, in Neuss (Germany). In this position I was responsible for Phase I clinical trials (first-in-man, pharmacodynamics, pharmacokinetics, drug interactions / analytics / statistics / data management / QC and QA). I acted as a member of numerous 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 participate 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 more than 20 years I work successfully as a free-lance consultant.

My activities centre on the preparation 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 registration process I have gained experience in the handling of deficiency letters.

As a member of drug development teams I take part in the early / advanced development of medicinal products. I am familiar with EMA and FDA guidances and strive for the best interpretation of these to achieve a lean development process.

In Scientific Advice procedures at the EMA, FDA and national Competent Authorities I take part in the preparation of Briefing Books including the identification of clinical and nonclinical questions to be asked together with the preparation of company positions to defend a development goal. I have actively presented the development strategy and debated with regulators.

For the preparation of clinical trials I have written the nonclinical and clinical part of Investigator's Brochures. This includes recommendations for the responsible physician (guidance for the investigator) based on pharmacological - toxicological findings and, where possible, existing trials on healthy volunteers or patients. The goal is to give a consolidated view on potential safety issues.

A further focus of my work is the management / co-operation in the Data Monitoring Committee (DMC), Data Safety and Monitoring Board (DSMB).

 

More information about my experience and qualifications are to be found in the Curriculum Vitae, my Publications list, see also Oral Presentations and Posters. I am a member of numerous established scientific associations, see Memberships in Scientific Associations.