Volker Blust

Senior Nonclinical Consultant and Toxicologist @Phox Consulting E.U

Vienna, AT

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 statementsTeaching / 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

Universität Wien

Dr. rer. nat.

Karlsruher Institut für Technologie (KIT)

Diploma

German Society for Experimental and Clinical Pharmacology and Toxicology

Certified Toxicologist (DGPT)