Brigitte Happ is an independent consultant of regulatory affairs. She has more than 25 years of extensive experience in global regulatory affairs for biotechnological and pharmaceutical companies and as an Independent Consultant.
Her expertise covers a broad range of therapeutic areas such as metabolic endocrinology, dermatology, oncology, therapeutic vaccines and urology as well as autoimmune and inflammatory diseases. Brigitte has a strong scientific background being able to bridge the gap between research and development.
As the founder of Happ consulting, she offers strategic regulatory advice for small and medium-sized companies as well as hands-on technical regulatory advice for scientific regulatory documents such as Health Authority Briefing Books, orphan designations, paediatric investigation plans and investigational new drug application and clinical trial application submissions. She further serves as the regulatory lead for health authority interactions. Brigitte is one of the coordinators of the masters in drug development module on regulatory affairs at the University of Geneva, Switzerland. She regularly provides training on regulatory aspects for drug development.
Brigitte obtained her doctorate degree in biology from the University of Cologne, Germany.