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

4 November 2020 | Online

Catch the latest updates on how to establish, expand and improve your Regulatory Information Management (RIM) system landscape by understanding the shift from a content/document approach to a data-centric approach.

Although much progress has been made and a well-established baseline is observed for RIM across the entire industry, there is still a journey ahead of us when it comes to the management of regulatory content. How far have companies managed to transition from content to a data-centric approach and how well are they prepared to do so in the future? What can we learn from those who have achieved this next level of maturity and which system capabilities should we consider key to supporting such a transformation?

In this webinar Steve Gens, Founder and Managing Partner of Gens & Associates will share a new perspective from the Gens & Associates 2020 World Class RIM benchmark that focuses on those companies who are much further ahead in realizing the promise of a data-driven approach for a progressive and sustainable future in the next 3-5 years.

Agnes Cwienczek, Amplexor's Head of Product Management and Consulting, will elaborate further on the shift from a content/document-focused towards a data-centric approach and the triggers facilitating the move, which will include a demonstration of practical examples.


Session A

4 November 2020 | 2:00 PM - 3:00 PM GMT


Session B

4 November 2020 | 5:00 PM - 6:00 PM GMT


Meet the Speakers

Agnes Cwienczek

Sinor 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

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.