Participants will learn how to utilize the ‘Single Place of Truth’ for cross functional collaboration, improving business transparency and information exchange of regulatory data across the enterprise, achieving Regulatory Information Excellence during medicinal product lifecycle. The amount of data gathered, stored, and managed in the pharmaceutical landscape today is vast, but companies still struggle with sharing vital medicinal information cross functional in a timely manner, which would allow for faster product recalls, quicker labelling updates, and cost effective changes. This workshop will run through the post-marketing lifecycle covering:
- 1. Regulatory Information Management (e.g. overview, definition, benefits, objective)
- Technology (e.g., infrastructure, pre requisites, Cloud)
- Single Place of Truth, Single Source of Truth
- Data (e.g., availability, granularity, location/storage, structured, unstructured)
- Process (e.g., ADRs, change of manufacturer, electronic submission)
- Data transparency and consistency (e.g. impact of change, visibility across enterprise)
Participants will understand the difference of structured to unstructured data, the impact of Regulatory Information Management on data consistency and how the medicinal product lifecycle can be addressed from the Single Place of Truth.
An additional registration fee is required for all preconference short courses.
Who should attend?
At the conclusion of this course, participants should be able to:
- Employ the ‘Single Place of Truth’ to improve Regulatory Information Management and data consistency during medicinal product lifecycle
- Identify processes and current technology to improve cross-business transparency and information exchange resulting in faster product recalls, quicker labeling updates, and cost effective changes