Accelerating Digital Innovation and Transformation in Regulatory Affairs
May 12, 2020 8:00 AM -
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5/12/2020 8:00:00 AM5/12/2020 9:00:00 AM Accelerating Digital Innovation and Transformation in Regulatory Affairs The digital transformation imperative has hit pharmaceutical R&D. Global biopharma regulatory bodies have taken note as they align even more than ever on their demands for electronic data and submissions as well as on regulatory requirements both pre- and post- approval. The COVID-19 pandemic has made this topic even more relevant for regulatory staff as they face clinical trial disruptions and potential longer term changes in the way we do things as regulatory professionals well as new regulatory guidances, etc.
For regulatory affairs leaders and professionals this evolution on how we conduct business is game changing as the function moves from pulling together dossiers from documents and spreadsheets to creating electronic submissions derived from digital data sources and conducting real-time monitoring and ownership of product, clinical, and safety data. The benefit of this change for regulatory departments is tighter relationships across their organizations, providing competitive advantage for their companies and attaining more strategic seats at the management and executive level tables.
In this forum we will explore how regulatory affairs leaders are approaching digital transformation in their respective company and their recommendations to the audience of best practices. We’ll get insights from data experts / strategic services partners helping to accelerate adoption of digital innovation for their clients.
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