Our Trainers

    Dr. Braun is a trained pharmacist with 20 years of experience in Drug Product Development. He received his Ph.D. in Pharmaceutical Technology at the University of Bonn and started his career in pharmaceutical industry as Head of Pharmaceutical Development at Rentschler Pharma.
    Laura has an extensive industrial experience in the development of drug products for the worldwide market, from scratch to registration, in accordance with GxP and ICH requirements.
    Dr. Tony Cundell worked for Merck Research Laboratories in Summit, New Jersey, as the Senior Principal Scientist in early phase drug development. Earlier in his career, he worked at a director level in Quality Control and Product Development organizations at the New York Blood Center, Lederle Laboratories, Wyeth Pharmaceuticals and Schering-Plough.
    Simon has spent 30 years working in clinical trials, mostly in the pharmaceutical industry but also including five years at the UK and European regulatory agencies.
    Dr. Denby is a Biochemical Engineer. Over the years he has worked at AstraZeneca, Oxford BioMedica and Becton, Dickinson and Company. In 2017 he founded BioFrey in 2017 and has revolutionised availability of extractable data and change notification practices around single use systems facilitating uptake of these systems.
    Qualified and experienced in business management, consulting and project management (MBA,PMP). Hanna is a business management consultant, having a considerable experience in companies undergoing restructuring, particularly as a result of privatization.
    Jan Harmsen has more than 40 years of industrial experience in research, development, design, and commercial scale implementation of processes in oil & gas, chemicals, food & beverage and minerals.
    Dirk’s first professional study was in Electronics and was successfully followed by a dedicated study in Instrumentation. In 1977 he joined a daughter company of Shell, the Dutch Oil Company N.A.M., where he initiallyworked as an Instrument Technician.
    Dr. Huemer works at the Austrian Medicines & Medical Devices Agency, participating in many assessments of scientific advice procedures, paediatric investigation plans and centralized marketing procedures in different clinical areas. He is a SAWP full member since 2014 and a PDCO full member since 2013.
    Paula Muniz is a Senior Associate with Dynakin’s Drug Modeling & Consulting (DMC) group. She is doctor in Pharmacy by the University of Navarra with a PhD in cardiovascular pharmacology.
    Helge Neidhardt has over 30 years of pharmaceutical development experience with biologics covering projects on high purity natural proteins, recombinant proteins, monoclonal and conjugated antibodies. He worked at Aventis Behring and at Sanofi in different responsibilities, leading internal as well as collaborative CMC projects through all stages of development with EMA and FDA.
    Franz Nothelfer is currently professional consultant for downstream processing and viral safety. Before his retirement in 2017, he was heading a position as associate director Protein Science at Boehringer Ingelheim Pharma GmbH & Co. KG.
    James Pink has over 20 years of experience in the medical devices industry including 10 years as a healthcare technology expert and lead auditor for a leading European notified body.
    Dr. rer. nat. Dipl. Ing Ute Reichert has more than 20-year experience in the biopharmaceutical and pharmaceutical industry, the last years as Head of an aseptic fill and finish production in Sandoz.
    Dr. Hans Rogl is a Biochemist by training and started his industry career as manager of a downstream process GMP production facility at Roche Diagnostics GmbH in Penzberg, Germany.
    Dr. Ross has over 35 years experience in the Generics Industry, the last 15 being at corporate level. He has been intimately involved in strategic planning, pipeline management and related activities.
    David Schwicker has biopharmaceutical consulting expertise spanning more than 25 years. Founder of ORPHA Strategy Consulting, and former Vice President with PAREXEL International in the United States. David is a sought-after expert for accelerating marketing authorization, time to launch, early patient and market access of ATMPs.
    Ing. Helmut Schütz studied Chemical Engineering in Vienna and he is an independent consultant in the domain of bioavailability and bioequivalence studies.
    Rob Walker is a Chartered Chemist and a Fellow of the Royal Society of Chemistry with degrees in Applied Chemistry and Instrumental Analytical Chemistry.