Steve Gens (Gens & Associates) & Agnes Cwienczek (Amplexor)
Many life science companies have undertaken a long journey to establish, expand, and improve their Regulatory Information Management system landscape throughout the past years.
Although much progress has been made and a well-established baseline is observed 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. In their research, they segmented “content” and “data” related RIM capabilities and took just the top performers to understand their journey and how they are investing. Steve will provide a viewpoint to where progressive organizations will be with their RIM programs in the next 3 – 5 years, the path to high performance based on 100 + companies analysis, and a governance model for data quality sustainability.
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. She will discuss the key capabilities of a data-driven solution and highlight the benefits to put data first. At the end of the presentation, Agnes will conclude with a demonstration of practical examples of how the Amplexor Life Sciences Suite is addressing the arising data-centric requirements of the industry.