Brigitte Happ PhD

Brigitte has more than 20 years’ experience in global regulatory affairs with the biotechnology company Serono and the pharmaceutical company Merck Serono. Her expertise covers a broad range of therapeutic areas including metabolic endocrinology, dermatology, oncology and auto-immune/inflammatory diseases and orphan drug development. She has worked on new drugs, biotechnology product development and full marketing authorisation applications. She has also managed product life-cycles,

including device Conformité Européene marking, in the European Union, Switzerland, Japan, Canada, Australia and the United States. She has had successful interactions with international health authorities for marketed products and development compounds.

She has a strong scientific background and is able to bridge the gap between research and development. She is a lecturer for diploma courses at the University of Geneva and postgraduate courses at the Swiss Federal Institute of Technology in Zurich.

She has created Happ-Consulting, which offers strategic and operational regulatory expert advice to small and medium-sized biotechnology, pharmaceutical and medical technology companies.