Thomas Schreitmüller holds a Diploma and PhD in Biochemistry from the University of Munich (Max Planck Institute for Biochemistry, Munich, Martinsried and Institute for Clinical Chemistry and Clinical Biochemistry University of Munich). In 1989 he joined Roche holding various positions in the biotech area (e.g. Analytical R&D, technical project management). Since 2003 Thomas was heading the department "Analytical R&D and Quality Control Biotech Products" at Roche Pharma Technical Operations in Basel, Switzerland. The department assumed responsibility for basic analytical research in the context of biotech products, was doing the analytical development and quality control of biotech development products and clinical supplies respectively, and was responsible for the quality control of Roche marketed biotech products (e.g. Roferon-A, Neupogen, Zenapax, Herceptin, Mabthera, Pegasys, Avastin) manufactured at Roche Basel. Since 2010 Thomas is the Global Lead for Regulatory Policy and Strategy for Biologics within Roche.Health-/Industry-Organisation Activities - 1989-present: Roche representation in various WHO-, ICH-, IFPMA-, EFPIA-, EBE-biotech working groups. Currently member of: EBE Regulatory & Technical Affairs Committee,IFPMA Biotherapeutic Working Group.Member of the Organizing Committee of the “CMC Strategy Forum Europe” http://www.casss.org, Member of the Scientific Planning Committee of the “PDA Workshop on Monoclonal Antibodies” http://www.pda.org/europe. Conferences, Lectures-Lectures on Analytical Biotechnology, Characterization of Biotech Products, Biotech Products Manufacturing, Biosimilars as well as Regulatory Issues associated with Biotech Products in conferences all over the world e.g. Argentina, Austria, Belgium, Brasil, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Dubai, Ecuador, France, Germany, Guatemala, India, Indonesia, Japan, Jordan, Malaysia, Mexico, Nigeria, Peru, Philippines, Poland, Portugal, Russia, South Africa, Spain, Switzerland, Thailand, UK, USA, Uruguay, Venezuela, Vietnam.