Webinar: The next Generation of RIM is here!

26 January 2016

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.

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.

 

Key Take-Aways

  • Industry Trends and Innovation Developments on Regulatory Information Management
  • Global Content Management supporting better Submissions Management
  • RIM industry status and why we are here again
  • RIM Strategic Value, Efficiency Gaps and Trends
  • How to get efficiency through the entire corporate RIM investment
  • RIM: A category in rapid evolution and change
  • Pursuing a World Class RIM
  • The key to an Integral, Agile RIM
  • RIM solution design
  • Business impact of a Product Data driven RIM
  • Assessments, Recommendations and Examples

Speakers

Steve Gens – Gens & associates Inc. – Managing Director

 

 

 

Romuald Braun – AMPLEXOR Life Sciences – Vice President Strategy Life Sciences