Volker Blust
Senior Nonclinical Consultant and Toxicologist at PHOX Consulting e.U.- Claim this Profile
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Bio
Experience
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PHOX Consulting e.U.
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Austria
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Senior Nonclinical Consultant and Toxicologist
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Oct 2021 - Present
Consultancy work • Preparation of product-tailored non-clinical development strategies for drugs (small molecules, vaccines) and medical devices (biodegradable implants, topical products, drug-device combinations, substance-based devices) • Design and monitoring of non-clinical studies (pharmacology, pharmacokinetic, toxicology) and interpretation of data • Preparation of response documents to non-clinical questions from EU national authorities, EMA and US FDA • Regulatory interactions, participation at scientific advice meetings at EU national Authorities • Authoring of regulatory documents: Investigator’s Brochure, Briefing Documents, Common Technical Documents and Biocompatibility Reports for various products, including small molecules, herbal preparations, biologics and medical devices • Preparation of toxicological risk assessments and expert statements Teaching / External trainings: • Impurity qualification • Calculation of permitted daily exposure (PDE) values in the context of shared facility production • Non-clinical drug development • Speaker at Forum Institut für Management Show less
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MC Toxicology Consulting GmbH
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Austria
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Pharmaceutical Manufacturing
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Senior Consultant: Non-Clinical Development
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Mar 2019 - Oct 2021
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Consultant: Non-Clinical Drug Development
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Feb 2016 - Feb 2019
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Junior Consultant - Non-Clinical Drug Development
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Aug 2013 - Jan 2016
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University of Vienna
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Austria
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Research Services
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700 & Above Employee
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Postdoc
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Mar 2012 - Jul 2013
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Education
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European Registered Toxicologist (ERT)
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German Society for Experimental and Clinical Pharmacology and Toxicology
Certified Toxicologist (DGPT), Training as a toxicologist (DGPT) -
Universität Wien
Dr. rer. nat., Food Chemistry - Toxicology -
Karlsruher Institut für Technologie (KIT)
Diploma, Food Chemistry