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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 8: Track 2: Digital Transformation of Regulatory Affairs embracing Advanced Technologies

Session Chair(s)

Michiel  Stam

Michiel Stam

Management Consultant

MAIN5 Gmbh & Co. Kgaa, Germany

Digital transformation is happening in rapid pace in every imaginable industry segment in a meaningful way. In this session, speakers will provide the insight to future of regulatory affairs in the digital world and how companies need to embrace advanced technology to disrupt the traditional way of handling regulatory information and submission process. This session will illustrate the use of artificial intelligence, machine learning, cloud computing, Internet of Things ( IoT), robotic process automation, voice assistant system to reduce the submission cycle time, increase efficiency and productivity, reducing cost of ownership, and increase of compliance adherence etc. in regulatory affairs.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Understand building blocks of digital transformation and rise of advanced technology
  • Define how to build a regulatory intelligence system using voice assistant and NLP
  • Illustrate how RWE gives a new paradigm shift for more predictable, effective, and value-based patient care
  • Demonstrate the benefits of cloud technology in regulatory operations

Speaker(s)

Amy  Cheung, MBA

Embracing Real World Evidence and Robotic Process Automation to Transform Regulatory Affairs Submission Process

Amy Cheung, MBA

Deloitte, United States

Principal

Marc  Gabriel

Achieving the Benefits of Cloud Technology in Regulatory Operations

Marc Gabriel

Veeva Systems, United States

Vice President, Vault RIM

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