my Career started many years ago as a Scientist at the University of cologne. atfer my diploma in Biology i decided for my phd to change from the e. coli galactose operon to plant tumor Research at the max planck institute for plant breeding Research, which i continued in freiburg. although i was offered a Postdoctoral fellowship i decided to change again to study the interleukin 1 receptor at the German Cancer institute in heidelberg. when i had the opportunity to work on the cd 72 b Cell surface antigen at stanford University i packed up and left for the us. i am particularly proud of my 3 year fellowship from the arthritis foundation. upon my return i felt that the academic environment was not what i wanted to do and consequently, i went to work for e. merck in darmstadt where i gathered experience in the Preclinical development of biotech products for Cancer therapy. my job at smith kilne beecham biologicals in belgium provided the opportunity to look at the next step of Drug Development, the regulatory procedures. i left because the position at ppta provided the oportunity to work on all different aspects of Pharmaceutical Development in the very special field of plasma derived medicinal products and their recombinant analogues. over 17 years i established several standing committees at ppta, i repesented the association at regulatory authorities on eu and national level and almost all submissions to the european medicines agency, the european directorate for the quality of medicines & Health Care and national competent authorities. in my role as the secretariate of the ppta Expert groups i was the first contact point for regulators and other kols.
Senior ConsultantBrussels area
Since December 2014
Senior Director Quality and Safety Brussels, BelgienJanuary 1998 --- November 2014
- preparation of consensus industry comments for regulatory authorities (eu, us, row).
- representation of consensus industry positions with regulatory authorities.
- coordination of peer reviewed Publications.
- Presentations for scientific audiences.
- development of position papers and press releases
Staff Scientist Darmstadt, DeutschlandJune 1991 --- May 1996
evaluation of new concepts for Pharmaceutical Development.
Research Scientist Heidelberg, DeutschlandJune 1986 --- May 1988
functional characterisation of the interleuki 1 receptor
Attention to detailWillingness to compromiseStrategic thinkingSelf-disciplineProactivityProblem solvingOrganizationInnovative thinkingFlexibilityDependabilityCuriosityCritical thinkingCollaborationCoordinationApproachabilitySelf-confidence
Biochemistry R&DAntibodiesBiological Drug DevelopmentBiopharmaceuticalsBiotechnologyCell CultureDrug regulatory authoritiesDrug Safety and PharmacovigilanceEarly development stageEMAFDAGeneticsGood Manufacturing Practice (GMP)HematologyImmunologyImmunoprecipitationInfectious diseasesKOL managementMarket accessMarketing Authorisation Application (MAA)Marketing approvalPediatrics
Skills and Expertise
Publication of articlesPublish scientific projectsRegulatory documentationRegulatory submissionsResearch at universitiesSearch literature on clinical trialsSolve problemsWrite papersWrite protocolsWriting regulatory documentsWritten presentation
PhD in Plant biology, biotechnology from Max Planck Institute for Plant Breeding Research, Cologne and University of Freiburg in 1986
Master in Biologie, biotechnology from University of Cologne, Germany in 1982
Expert has 18 publications (Will be avalible with full profile)