Louis-Christian Clauss

Dr. Clauss has over 30 years of experience spanning from International Regulatory Affairs (EMEA, FDA, EU National Global development) to new product development and Quality Assurance/ ISO certifications. He served as a Resident Biologist in Public Hospitals before moving to the Multinational Health Care Industry both in the Medical Devices field and in Pharmaceuticals (Institut Mérieux, now Sanofi Aventis; Dow Corning; Boston Scientific; Clintec; Becton Dickinson; Baxter). He was the Global Director Regulatory Affairs New Product Development, BioScience, for Baxter World Trade. In those posts, he led the development of numerous products including pharmaceuticals, stents, implantable devices, and biotherapeutics, Cprotin, CD20, AdNC, including biosimilars, EPO, rFactorVIIa.

Dr. Clauss has been involved in over 75 regulatory submissions and 30 agency meetings with EMA and FDA. He has more than 70 publications and conference presentations, and is a member of numerous Professional Societies, including DIA, RAPS (former General Secretary, RACS), EUCOMED (former chairman of the FRG), and APIMCA (former President elect).

Dr. Clauss holds a Masters degree in Bio-Pharmacy, a PhD in Pharmacy and a degree in Business administration (IAE).