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Virtual

Mar 15, 2021 9:00 AM - Mar 19, 2021 4:30 PM

(Central Europe Standard Time)

DIA EUROPE 2021

Transforming Regulatory Affairs

Session Chair(s)

James  Kelleher, MA

James Kelleher, MA

CEO

Generis, United States

Max  Kelleher

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 Regulatory Affairs can often be subject to outdated processes which involve standardising on a core RIM solution at a global level, and using this to build primary submissions before these are passed to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)

Eric  Cardwell, MBA

Regulatory Transformation

Eric Cardwell, MBA

AbbVie, United States

Director, Regulatory Information Management

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