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Bethesda North Marriott Hotel and Conference Center

2022 年 02 月 14 日 8:30 上午 - 2022 年 02 月 16 日 2:15 下午

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

Regulatory Submissions, Information, and Document Management Forum

Session 10 Track 4: Making Digital Transformation Real

Session Chair(s)

Peter  Terbeek, MBA

Peter Terbeek, MBA

Senior Director, Regulatory Operations

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)

Olaf  Schoepke, PhD

Speaker

Olaf Schoepke, PhD

Samarind, United Kingdom

Vice President, Regulatory Solutions

Susant  Mallick, MBA

Speaker

Susant Mallick, MBA

Cloudhub BV, Netherlands

Founder and CEO, Life Sciences Practice Leader

Karin  Schneider, MLIS, MS

Speaker

Karin Schneider, MLIS, MS

Johnson & Johnson Innovative Medicines, United States

Associate Director

Keith  Schlaudecker

Speaker

Keith Schlaudecker

Merck & Co., Inc., United States

Associate Director, Information Integration and Label Management

Jennifer  Wemstrom

Speaker

Jennifer Wemstrom

Google, United States

Life Sciences Cloud Strategist

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