Meet the expert...

Kelly Hnat

Principal at K2 Consulting

Kelly Hnat
Kelly Hnat is a leader in RIM and IDMP with 25 years' experience in the biopharmaceutical industry leading IT, RIM, and Regulatory Operations organizations.  Kelly is a globally recognized expert in IDMP and is a key 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.  Additionally, she is a member of ISO TC215/WG6 (the ISO group responsible for the IDMP standards), is a member of the Core Research Team for the Gens & Associates World Class RIM survey, and serves as President/CEO 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.
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