About the video

Video recording from Day 1 Be The Expert 2022 virtual conference featuring:

1. Kelly Hnat, K2 Consulting: Preparing for IDMP in times of uncertainty: What now?
2. Steve Gens, Gens and Associates: Industry RIM status: How are companies evolving and investing in the near and longer term?
3. Agnes Cwienczek, Amplexor Life Sciences: The Impact of IDMP on Regulatory Information Management

About the speakers

Kelly Hnat is a leader in RIM and IDMP with over 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 sub team, and the SPOR EU Implementation Guide Focus Groups.  Additionally, she is a member of ISO TC215/WG6, 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.

Steve Gens (MSOD) is the Managing Partner of Gens & Associates Inc., A Life Science benchmarking and advisory firm specializing in performance improvement, strategy, regulatory information management, and organizational transition. His early career was spent at Johnson and Johnson in a variety of management positions and then transitioned to consulting where he led global Life Science consulting practices for First Consulting Group and Booz Allen Hamilton.

His organization is well known for their insightful industry benchmarks, World Class RIM industry performance standard, and thought leadership. Steve has a Bachelor of Science in Business Computer Science and a Master in Organizational Development. He is a frequent speaker, has many publications, and was named to the 2017 PharmaVoice 100 and as an innovator in the 2021 Innovations in Pharmaceutical Development™ for his contributions to industry.

Agnes has been in the position of ALSS Head of Product Management and Consulting since May 2017. Her main responsibilities are the contribution to the development and enhancement of the Amplexor Life Sciences Suite, supervision of the Life Sciences Consultants as well as the provision of business process and data management expertise to Amplexor clients in Regulatory Information Management, Document Management, and Submission Management.

Before joining Amplexor, Agnes worked at Merck KGaA in Global Regulatory and Quality Assurance, where she was acting System and Process Owner for all regulatory owned systems, providing global leadership for the management of submission documents, regulatory data and archiving within the Merck Biopharma organization.