Kelly Hnat

Principal at K2 Consulting, USA

Kelly Hnat has over 25 years' experience in the biopharmaceutical industry leading IT, RIM, and Regulatory Operations organizations in several companies. Kelly serves as a subject matter expert supporting the EU implementation of IDMP as a member of the EMA SPOR Task Force, the SPOR PMS subteam, and the SPOR EU Implementation Guide Focus Groups. She is also on the Core Research Team for the Gens World Class RIM survey and serves as President of IRISS Forum, a global nonprofit organization that brings together industry, vendors, and health authorities to address topics related to submission standards. Kelly leads K2 Consulting, a boutique consultancy that provides business process, organizational strategy, and technology strategy services for Regulatory Affairs organizations.