PART I: Industry Trends and recent Innovative developments for RIM
PART II: Getting more value and flexibility out of your RIM Program
By attending this webinar you can get 1 RAC Credit.
The traditional approach to managing data and content separately has been driving the modularity of respective focused applications in the Life Sciences industry. Those applications, developed to support specific parts of a process, were built proprietary, with a simplified data model and needed to be interfaced with each other to attempt to support the end to end process. Both aspects led to increasing complexity and exponential maintenance efforts of such systems and interfaces.
Regulatory Information Management (RIM) including submission, document, process and data management has been challenged by permanent changes in regulatory standards resulting in higher standards for the delivery of consistent data and content to Health Authorities (HA’s). One timely example of this is the recent ISO IDMP/XEVMPD or eCTD Module 1 requirements.
On one hand, proper Regulatory Information (RI) relies on proper Master Data (MD). On the other hand, RI can also become part of MD itself. The question arises, what boundaries and synergies can be identified and utilized? What setups would allow mutual leveraging in order to positively impact business process designs to increase and sustain a company’s competitiveness and efficiency?
The use of an Integral design model within solutions for managing content, processes and data, enables an entity (object) oriented approach; processes and data can therefore be managed within the same entity model. In this context, structured authoring becomes a natural element of the overall capability as data entities can drive automation of content entities and in this way ensures their consistency.
By attending this webinar, you will know and understand the most recent Innovative developments for RIM (Regulatory Information Management), the industry status and why we are here again, its Strategic Value, Efficiency Gaps and Trends and still, how to get efficiency through the entire corporate RIM investment in this rapid evolution and change environment.
Presented by
Steve Gens,
Managing Director
Steve Gens is the Managing Partner of Gens and Associates Inc., a global Life Science consulting firm specializing in strategic planning and roadmap design, regulatory information management, industry benchmarking and organizational performance. His early career was spent at Johnson and Johnson in a variety of management positions and then moved into consulting to grow and lead several global healthcare consulting practices for First Consulting Group and Booz Allen Hamilton.
His organization is well known for their insightful industry benchmarks that research important topics such as RIM, Next Generation Content Management, Regulatory Operations efficiency and information management at local affiliate office and regional hubs.
Steve has 30 years of experience, a Master of Science in Organization Development and undergraduate degree in Business Computer Science.
Romuald Braun,
Vice President Strategy Life Sciences
Since 1992 Romuald Braun has been working in roles related to Compliance, Document Management, Content Management in the Life Sciences industry. Romuald has been playing roles on the client side and in consulting, in delivery and in sales, in project roles and in line responsibility. He worked in client server and in cloud environments, in Europe and in US.
Romuald is holding the academic degree of Master of Drug Regulatory Affairs in addition to his Engineer diploma in Data Technology. Romuald has been also a frequent speaker on topics relating to content management adoption in life science
