Module 12 2019

Direction of Travel…

• Move from Document based to Structured Data

Specialism on core tasks • e.g. who should track a Company Core Data Sheet rather than be accountable for it

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• Intelligent Innovation to facilitate •

Generation of documents from data • Automated Submission Content Plans & timelines • Simultaneous, automated Global Dossier Creation • Analytics to enable visualisations of compliance status

The Organisation for Professionals in Regulatory Affairs