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Bethesda North Marriott Hotel and Conference Center

Feb 11, 2019 7:00 PM - Feb 13, 2019 8:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Session 10: Track 2: Regulatory is Boring

Session Chair(s)

Jake  Doran

Jake Doran

Vice President, Digital

Lykos Therapeutics, United States

This session will focus on the impact of technology, efficiency, knowledge management, and how the consumer information paradigm will impact the future of RIM. In the very small niche market of pharmaceuticals and biotechnology, the established vendors are well known…but are they? Current software and solutions grew directly out of regulatory requirements at global health authorities. As standards evolve, companies look to change systems to maximize value, streamline operations, decrease total cost of ownership, and increase compliance. The future of digital technology and the influx of Behemoth Tech companies into Pharmaceutical Operations is going to change everything. The impact of big technology R&D money now focused on this area will influence the pharmaceutical operational landscape in ways we may not yet fully understand. What was once a playing field of upstart companies is now big opportunity for tech giants to change the way we do business and get medicine to patients faster and in novel ways. This session will illustrate how technology, innovation, and fresh perspective can transform regulatory stuff from boring to indispensable.

Learning Objective : At the conclusion of this session, participants should be able to:
    Recognize ways technology, efficiency, knowledge management, and the consumer information paradigm will impact the future of RIM

    Speaker(s)

    Matt  Neal, MA

    Regulatory is Boring

    Matt Neal, MA

    Atara Biotherapuetics, United States

    Senior Director, Regulatory Affairs Operations

    Meredith K Sewell

    Regulatory Transformations – Incremental Change Brings Monumental Gain

    Meredith K Sewell

    Sarepta Therapeutics, United States

    Vice President, Regulatory Operations

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