Christa Wirthumer-Hoche studied biochemistry TU Vienna, doctoral thesis at Medical Physiology. Starting at the AT Nat. Inst. for Quality Control of Drugs - quality assessment, Head of Regulatory Affairs in the Ministry of Health, Now Head of the Austrian Medicines and Medical Devices Agency. Christa is the elected Chair of the EMA Management Board.

Member of AIChE, ACS, ISPE, APV, Catalysis Society of Metropolitan New York Consultant for Bristol-Myers Squibb, Merck, Energia, DuPont, Schering Plough, Novartis, etc. Reviewer of Journal Articles, Textbooks, NSF, DOE Editor special issue of Chemical Engineering Science on Pharmaceutical Engineering Member Editorial Advisory Board American Journal of Chemical Engineering Member Editorial Board Powder Technology

Implementation, coordination and maintenance of quality systems (GMP, HACCP, Quality Risk Management). Application of integrated principles of QbD, PAT, DoE and statistics for pharmaceutical development and deviation management. Responsible for product launches and scale-up, process validation, cleaning validation and equipment qualification.

Dr. Fritz Erni has a Ph.D. from the Swiss Federal Institute of Technology (Dr. sc.nat. ETH) in Zurich and more than 35 years experience in research, development and quality assurance in the pharmaceutical industry.

2010 - Freelance consultant for biotechnology (ICB Consulting) 2003 - 2010 F.Hoffman-La Roche in Basel, Switzerland, Head of Biotech Manufacturing 2000 - 2003 Aventis Pharma Vice President, Global Head Process Development Biotechnology 1997 – 1999 Rhône-Poulenc Rorer Vitry, France 1974 - 1997 F.Hoffmann-La Roche in Basel, Switzerland