Regulatory master plan for the development of new drugs, especially Phase I
Preparation of Clinical Trial Applications
Orphan Drug Applications
Management of New Drug Submissions for marketing authorization
Establishment of Health Authority contacts to obtain scientific advice (EMEA and National Health Authorities EU)
Preparation and conduct of meetings with Health Authorities
Drug Regulatory Affairs Specialist
Studied medicine at the Free University of Berlin. For almost 10 years I worked as researcher in central nervous system physiologyre and received a professorship in Physiology at the Free University of Berlin. Main areas of research: reticular formation of the brain stem, amygdaloid complex as part of emotional behaviour. Thereafter, I worked for 4 years in cardiovascular drug discovery at Schering AG followed by 3 years as head of research management. From 1993 til 2007 I worked in Drug Regulatory Affairs at Schering. In 1998 I became Global Head of Corporate Regulatory Affairs with responsibility for all new drug developments, approvals and the maintenance of all approved drugs of the company. Since 2007 I work as a Regulatory Specialist for bubag-medconsult. Due to my regulatory experience in drug development and the experience interactions with Health Authorities worldwide, I am capable to set up pragmatic solutions to obtain clinical trial permissions and to establish contact with health authorities to get scientific advice on development plans.
Qualifications
More then 24 years of experience in drug discovery, drug development and drug regulatory affairs
State examination in medicine
Dr. med.
apl. Professor of Physiology, University Medicine Charité Berlin
Since 1993 worked in Drug Regulatory Affairs. Between 1998 and 2007 Head of Corporate Regulatory Affairs of Schering AG. Responsible for numerous New Drug Applications and Approvals in Europe, Japan, USA and other countries. Regulatory expertise for small molecules, biotech products, cell and gene therapy. Since 2007 I work as a regulatory specialist for bubag-medconsult, a consultancy, and helped a small company to prepare their first new drug submission and negotiated the approval in the EU.
