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Transforming Regulatory Affairs
Session Chair(s)
James Kelleher, MA
CEO
Generis, United States
Max Kelleher
COO
Generis, United Kingdom
In this session we will be looking at transforming the way you think about Regulatory Affairs and the approach to best practices. Regulatory Affairs can often be subject to outdated processes which involve standardising on a core RIM solution at a global level, and using this to build primary submissions before these are passed to affiliates to amend for their local markets. AbbVie and Generis are collaborating to build a unified platform with rich content creation tools, off the shelf, including structured and collaborative authoring tools, and the ability to combine documents, with rich management information and process insights – in other words, new visibility across everything. Simplifying complex IT estates and overcoming information silos is a growing priority as part of digital transformation initiatives at many large life sciences organisations as they strive to be more agile and cost-efficient, while improving speed to market.
Speaker(s)
Regulatory Transformation
Eric Cardwell, MBA
AbbVie, United States
Director, Regulatory Information Management
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