Manfred Bodenlenz

About

Experience

• JOANNEUM RESEARCH (23 yrs 6 mos)
  • PRRC (Responsible Person for Regulatory Compliance) for Medical Devices under MDR
    May 2021 - Present · 5 yrs 2 mos

  • PK-PD/BA-BE of topical drug products
    Jan 2003 - Present · 23 yrs 6 mos

    Topical Drugs, Transdermal drug delivery, Drug development, De-risking and Compound selection studies in pigs for drug candidates based on total and unbound dermal drug concentrations, Clinical Trials, Early Clinical PoC trials/Microplaque studies including interstitial local dermal PK-PD per dOFM, Preclincal trials, Open Flow Microperfusion (OFM) and Microdialysis trials(MD), Collection of human skin(fresh&frozen), Topical penetration and metabolism testing in excised human skin fresh&frozen (dermal OFM, MD, Tape stripping, biopsies, skin slicing ..), Topical bioequivalence trials in human volunteers(dermal OFM), Microdosing trials in human volunteers (dermal OFM), Protocol Writing, Ethics application, Project Management, Scientific Publications, Medical Device Development, Medical Device Testing, Medical Devices trials, Person Responsible for Regulatory Compliance (PRRC) according to the Eur. Medical Device Regulation (MDR) since 2022, under MDD "Safety Officer" since 2009.

  • Safety Officer for Medical Devices under former European MDD Directive
    Jan 2009 - May 2021 · 12 yrs 5 mos

• WP-Leader for In Vivo Methods at European COST Action SkinBad on Atopic Dermatits
  2009 - 2013 · 4 yrs

• Junior Researcher at Medical University of Graz
  1999 - 2003 · 4 yrs

  Clinical Trials, Medical Device Development, Medical Device Testing, Artifical Pancreas, Algorithm Testing, Insulin Studies, Tracer Studies, Endogenous Glucose Release, Data Management, Statistics, Scientific Writing