Module 12 Presentations

Trends in the market for regulatory information management

Organizational processes

01

Increases in RIM performance status

▪ Maximalization of RIM system benefits (mid, large companies) ▪ RIM system/process simplifications

Increased industry focus on implementing data quality practices and cross functional data governance strategies.

Regulatory initiatives

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Increase data quality of authoritative sources Access to real-time information Redefining and clarifying roles and responsibilities SPOR/IDMP/DADI planning and implementation Data Submissions (small companies) Introduction of the eCTD 4.0 (projects within 2 years)

02

Shift in RIM team focus

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Data Governance

03

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Data Governance in early adoption

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Change management

04

Challenges in change management

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Cross-functional process integration Improved information exchange

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Reduction of operational complexity

The Organisation for Professionals in Regulatory Affairs