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Session 8: Track 2: Digital Transformation of Regulatory Affairs embracing Advanced Technologies
Session Chair(s)
Michiel Stam
Director Regulatory Information Management
Qdossier - A Celegence Company, United Kingdom
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)
Embracing Real World Evidence and Robotic Process Automation to Transform Regulatory Affairs Submission Process
Amy Cheung, MBA
Deloitte, United States
Principal
Achieving the Benefits of Cloud Technology in Regulatory Operations
Marc Gabriel
Veeva Systems, United States
Vice President, Vault RIM