Ing. Helmut Schütz

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Guideline Updates

ICH 2019-11-20 Guideline on BCS-based bio­waivers
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ICH 2019-02-26 Draft guide­line bio­analytical method validation
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FDA 2019-02-19 Draft Guidance: BA and BE Studies Submitted in NDAs or INDs
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EMA 2018-08-03 Product-specific guidances
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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FDA 2014-05-14 Draft Guidance: Clinical Phar­ma­co­logy Data to Sup­port a Demonstration of Bio­si­milarity to a Refe­rence Product
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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 com­pa­ra­tive bio­avail­ability 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 forty 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 Association for Applied Human Phar­ma­co­logy (AGAH), 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