Ing. Helmut Schütz

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News

EMEA/FDA 2009-08-03: GCP Initiative
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WHO 2008-04-25: BCS-Update.
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Highly Variable Drugs

US-FDA 2006-10-06: Meeting of the Advisory Committee for Pharmaceutical Sciences.
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Guidances

EU-EMA 2010-01-29: Guideline on the Investigation of BE
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Can-HPFB 2010-01-25: Comparative Bioavailability Studies.
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EU-EMA 2009-11-19: Bioanalytical Method Validation
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EU-EMEA 2009-07-23: Q&A document
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EU-EMEA 2008-07-24: Revision of the Guideline on the Investigation of BE
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EU-EMEA 2007-10-18: Advice to Applicants / Sponsors / CROs of BE Studies.
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Japan-NIHS 2006-11-24: Revision of BE-Guidelines.
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EU-EMEA 2006-07-27: Questions & Answers Document to NfG on BA/BE.
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Consultancy Services for Bioequivalence and Bioavailability Studies

BEBAC specializes in providing biostatistical services, contractor selection and supervision. We have wide experience with bioanalytics, pharmacokinetics, and biostatistics.
Our professional expertise covers advisory activities, planning and analysis of Phase I clinical trials.
We are able to support you in planning and evaluation, responding deficiency letters, as well as preparation for regulatory hearings, placement and evaluation of CROs.

Helmut Schütz studied Chemical Engineering in Vienna and is an independent consultant in the domain of bioavailability and bioequivalence studies.
Mr Schütz has worked in the pharmaceutical industry and in an independent CRO, where he established a GLP certified laboratory information management system, holding senior management positions, most recently as the head of a biostatistical department.
He has extensive experience with bioanalytics, pharmacokinetics, and biostatistics. His professional experience covers 30 years and more than 500 BA/BE studies. For the past five years he has been working to set up BEBAC.

Helmut Schütz is a member of the Drug Information Association (DIA), the International Pharmaceutical Federation (FIP), the International Society for Clinical Biostatistics (ISCB), the International Biometric Society (IBS), the European Network for Business and Industrial Statistics (ENBIS), the Austrian Pharmaceutical Association (ÖPhG), and the Austrian Association of Consulting Engineers (FI).

Short CV

Next Workshop:
October 25^th 2010, Munich, Germany