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Dr. Fritz ERNI Consultant; retired Head, Technology Liaison, Global Quality Operations, Novartis Pharma AG, Dornach


1969 Ph.D. from the Swiss Federal Institute of Technology (Dr. sc.nat. ETH) in Zurich
 Started his career in Japan in research at Hitachi Ltd.
1974-1986 Several positions in the analytical research and development of new drug substances and products at Sandoz in Basel
1986-1995 Head of Analytical Research and Development at Sandoz in Basel
1995-2000 Several management positions in Quality Assurance/Control at Sandoz and after the merger within Novartis
2000-2002 Director of Novartis Pharmanalytica SA in Locarno, Switzerland
2002-2009 Head of Technical Liaison, Global Quality Operations of Novartis in Basel (responsible for the establishing of Novartis Global activities on Process Analytical Technologies (PAT) and Quality by Design)
 Since 2009 Consultant (retired from Novartis after 35 years in the pharmaceutical Industry)


Lector for Analytical Chemistry for advanced students in Chemistry at the Swiss Federal Institute of Technology in Zurich
since 1992 Topic leader of the European Industry (EFPIA) for impurity topics for the International Conference on Harmonization (ICH) and involved in the elaboration of the impurity ICH guidelines for impurities in drug substances, impurity in drug products and residual solvents
Member of the ICH Expert Working Group Q8 on Pharmaceutical Development and the ICH Q8/Q9/Q10 Implementation Working Group


published more than 50 papers