This site is part of the Informa Connect Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 3099067.

20th - 22nd April 2021
★ 100% virtual conference ★Presented in Central European Time (CET)

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.

Agenda Sessions

  • The SPOR Target Operating Model (TOM) – Understanding the impact on your Submissions and Processes”