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Session 10 Track 4: Making Digital Transformation Real
Session Chair(s)
Peter Terbeek, MBA
Executive Director, Regulatory Data and Document Operations, Astellas Pharmaceuticals, United States
Can machine learning and voice assistants really help us build a regulatory intelligence system? This session will identify Digital Transformation opportunities in the submissions space and advise on how to position this type of business case within your organization. Representatives from prominent technology companies will join Regulatory Operations leads from leading Pharma companies to discuss opportunities, obstacles and how to get beyond the buzzwords to bring meaningful change.
Learning Objective : - Distinguish between digitization and digital transformation
- Identify use cases that can leverage new technologies to significantly change how submissions are planned and/or prepared
- Understand how agency transformation activities can impact submission operations
- Identify ways to use AI and machine learning to incorporate RWE data into submission strategies
Speaker(s)
Speaker
Olaf Schoepke, PhD
Vice President, Regulatory Solutions, Samarind, United Kingdom
Speaker
Susant Mallick, MBA
Founder and CEO, Life Sciences Practice Leader, Cloudhub BV, Netherlands
Speaker
Karin Schneider, MLIS, MS
Associate Director, Johnson & Johnson, United States
Speaker
Keith Schlaudecker
Associate Director, Information Integration and Label Management, Merck & Co., Inc., United States
Speaker
Jennifer Wemstrom
Life Sciences Strategy Lead, Google, United States
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