Dr. Axel F. Wenzel, PhD, MSc, MBira
 
Dr. Axel F. Wenzel (PhD, MSc, MBira) is the Managing Director of p.ss.t Pharma Scientific Services Team Ltd., a service provider and consulting company for drug and medical device development.

He holds a Ph D and a M Sc degree in microbiology from the German University of Saarland/Saarbrücken.

Dr. Wenzel is President of TOPRA (global organisation for professionals in Regulatory Affairs) and was President of PEFRAS (Pan European Federation of Regulatory Affairs Societies) and one of its member associations, i.e. MEGRA (Mid European Society for Reg. Affairs Professionals). He also chairs the Publications Committee of the European Society of Regulatory Affairs, the ESRA Rapporteur and is one of the governors of EAPB, the European Association of Pharmaceutical Biotechnology.

He has more than 20 years experience in pharmaceutical R&D, "from transcription to prescription", both from preclinical and clinical side. He hold several positions in well known pharmaceutical companies like SANDOZ, BIOCHEMIE or MSD Sharp & Dohme and also at an university hospital. At SANDOZ Research Institute / Vienna headed multidisciplinary preclinical project teams. During a one year training on the job in all relevant departments of a medium sized pharmaceutical company (Biochemie GesmbH) further experience was added.

National and international Organisation of Research and Project Management was continued at MSD Sharp & Dohme in Germany. In these positions responsibility focused at pre- and clinical drug development, Regulatory Affairs and also (pre-) marketing of medicines with special emphasis on Phase III planning, Opinion Leader development and electronic submissions.

Furthermore, experience in Health Economics, cost analysis, data base/management information systems development, licensing, training and other issues was developed.

Axel Wenzel is lecturer at the university of Witten, the first German private university and the Fachhochschule (technical university) of Isny. Some 50 publications and numerous presentations are a proof of this competence in biomedical and pharmaceutical Regulatory Affairs and Project Management..
 
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