Dana Nohynek holds senior management and consultancy roles with organizations in Canada, the United States, and Europe, providing regulatory leadership through all
phases of drug development, from entry into first-in-human studies to preparation and conduct of regulatory decision-making trials. With over 20 years of regulatory
experience, Dana has prepped and led countless interactions and negotiations with the US FDA and Health Canada. She navigates multidisciplinary teams through the regulatory
landscape, from pre-IND consultations to IND life-cycle management, as well as successfully executing extensive CTAs for drug products and biologics. Furthermore,
Dana is well-versed in medical device product development, achieving multiple successful marketing authorizations.

Dana Nohynek holds senior management and consultancy roles with organizations in Canada, the United States, and Europe, providing regulatory leadership through all
phases of drug development, from entry into first-in-human studies to preparation and conduct of regulatory decision-making trials. With over 20 years of regulatory
experience, Dana has prepped and led countless interactions and negotiations with the US FDA and Health Canada. She navigates multidisciplinary teams through the regulatory
landscape, from pre-IND consultations to IND life-cycle management, as well as successfully executing extensive CTAs for drug products and biologics. Furthermore, Dana is well-versed in medical device product development, achieving multiple successful marketing authorizations.