Regulatory is becoming less document- and more data-driven due to the upcoming implementation of new data standards, such as IDMP, FMD, FDA's PQ/CMC and Health Canada's implementation of the Structured Product Monograph as well as operational changes on the regulator side, such as EMA's implementation of SPOR. This is driving a new generation of Regulatory Information Management (RIM) systems and platforms supporting a broader, cross-functional data scope impacting a broader set of stakeholders across the organization. Stakeholders who use and understand the data differently in different contexts.
Consequently, the key to realizing the promised business benefits in terms of increased efficiency and better integrated business processes and IT systems becomes the establishment of a robust cross-functional data governance to ensure a) a common understanding of the data b) high quality regulatory data and c) avoid the garbage in, garbage out pitfall.
In this webinar, guest presenter Jens-Olaf Vanggaard of Highpoint Solutions will:
- Provide a perspective on best practices for data governance
- Explain why it is essential to the new generation of RIM systems
- Share industry experiences with regard to data governance
- Provide a practical approach to get started with data governance