Ing. Helmut Schütz

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News

EMA 2018-08-03 Product-specific guidances
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ICH 2018-06-27 Draft Guideline on BCS-based bio­waivers
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FDA 2018-05-21 Guidance on Bioanalytical Method Validation
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FDA 2017-12-21 BCS-based Biowaivers
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FDA 2017-10-24 Drug-drug Interactions
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ICH 2016-10-07 Concept Papers on BCS- based bio­waivers and bio­analytical method validation
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FDA 2016-12-21 ANDA Submissions ― Refuse-to-Receive Standards
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HPFB 2016-04-18 BE Standards for HVDPs
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EMA 2015-11-19 Q & A document
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EMA 2014-11-20 Guideline on MR dosage forms
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EMA 2014-10-23 Guideline on similar biological medicinal products
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FDA 2014-05-14 Draft Guidance: Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product
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FDA 2014-03-18 Draft Guidance: BA and BE Studies Submitted in NDAs or INDs
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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 biostatistics, pharmacokinetics, and bioanalytics.
Our professional expertise covers advisory activities, planning and analysis of Phase I clinical trials.
We are able to support you in designing and evaluating studies, responding deficiency letters, as well as in the preparation for regulatory hearings, assessment 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 GALP-certified LIMS and held 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 38 years and more than 600 BA/BE studies.

Helmut Schütz is a member of the International Pharmaceutical Federation (FIP), the European Fe­de­ration for Pharmaceutical Sciences (EUFEPS), the American Association of Pharmaceutical Scientists (AAPS), the International Biometric Society (IBS), the Austrian Pharmaceutical Association (ÖPhG), the European Net­work for Business and In­dustrial Statistics (ENBIS), and the Austrian As­so­ciation of Consulting Engineers (FI).

 Short CV

Out of office dates

Upcoming presentations
24 September (Amman), 27 September (Prague), 7–9 November (Athens).

I’ll be on sabbatical leave from November 15^th until January 31^th. These days, it will be difficult for me to read e-mail, and even more to answer.