Webinar on demand

RIM – Is data-driven Regulatory Information Management your reality?

Although observations show that progress has been made for RIM across the industry, there's always room for more improvement.


Watch our webinar for tips on how to expand and improve your RIM system landscape.

In this session, you'll learn about: 

  • The shift from a document approach to a data-centric approach
  • Which system capabilities can be used for system transformation
  • Practical examples, including a demonstration, on how to implement a transition
  • …and more

Watch now for free

Meet the speaker

Agnes Cwienczek

Agnes Cwienczek, Senior Life Sciences Consultant, Amplexor

Agnes has been in the position of Senior Life Sciences Consultant for Amplexor since May 2017. In her role as Life Sciences Consultant, Agnes is part of the Product Management team. 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.


Steve Gens

Steve Gens, Managing Partner, Gens & Associates Inc

(MSOD) is the Managing Partner of Gens & Associates Inc., a global Life Science consulting and benchmarking firm specializing in strategic planning, regulatory information management (RIM) program development, industry benchmarking, and organizational performance. 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’s of Science in Business Computer Science and a Master in Organizational Development and Performance. He is a frequent speaker, has many publications, and was named to the 2017 PharmaVoice 100 and 2020 R&D Innovations for his contributions to industry.