Fernanda Manhães

Fernanda has a PharmD degree and a Master in Health Economics and Pharmacoeconomics, with more than 10 years of experience in Regulatory Affairs having assisted pharmaceutical companies in all stages of growth, from start-ups to established multinationals needing assistance with the global regulatory strategy to filings in Europe, US, and Brazil. Her career in Regulatory Affairs focusing in the Clinical Department started in 2018 at an innovative Swiss pharma & biotech company focused on Rare Diseases, where she was accountable for the Investigational New Drug for orphan diseases portfolio at FDA and SwissMedic. In her career as an Independent Consultant, she provides ad-hoc training in Clinical Regulatory, consults the team on Regulatory assessment during clinical and pre-clinical development, and assesses departments Standard Operational Procedures seeking efficiency in the way of working.