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Trainers

  • Dr. Malcolm Ross
  • President
  • Generapharm, Switzerland

Dr. Ross has over 30 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. His early industrial experience with Teva and Taro were directed primarily to the US markets but later as President of IPR, a company jointly owned by PAR and Merck Generics followed by R&D director for Polpharma, his role expanded to include development for the European markets. Technically Malcolm specializes in development, both of formulations and analytical methodologies and holds a number of patents for novel formulations. He has set up R&D departments from scratch and has been responsible for upgrading existing units to European standards. Experienced in GMP and QA issues Malcolm has carried out many audits worldwide, both for API and Finished dosage forms. In 2006 Malcolm moved to Basel and established Generapharm, a training and consultancy company.

  • Ing. Helmut Schütz
  • CEO, BEBAC - Consultancy Services for BE and BA Studies
  • BEBAC, Austria

Helmut Schütz studied Chemical Engineering in Vienna and is an independent consultant in the domain of bioavailability and bioequivalence studies. Mr Schütz has worked in the pharmaceutical industry and in an independent CRO, where he established a GLP certified laboratory information management system, holding senior management positions, most recently as the head of a biostatistical department. In 2004 he founded the consultancy company BEBAC. He has extensive experience with bioanalytics, pharmacokinetics, and biostatistics. His professional experience covers 36 years and 600+ BA/BE studies. Helmut Schütz is a member of the International Pharmaceutical Federation, the European Federation for Pharmaceutical Sciences, the American Association of Pharmaceutical Scientists, the International Biometric Society, the Austrian Pharmaceutical Association, and the Austrian Association of Consulting Engineers.

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