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Feb 08, 2021 10:00 AM - Feb 10, 2021 4:30 PM

(Eastern Standard Time)

Regulatory Submissions, Information, and Document Management Forum

On Demand 3 Track 2: Using Intelligent Automation and Advanced Technology to Enhance Regulatory Performance

Session Chair(s)

Venkatraman  Balasubramanian, PhD, MBA

Venkatraman Balasubramanian, PhD, MBA

SVP and Global Head, Industry Solutions - Healthcare and Life Sciences

Orion Innovation, United States

Life Sciences companies continue to work towards more efficient and compliant regulatory business processes and effective management of regulatory information. With the advent of intelligent automation (IA) technologies such as robotic process automation and natural language processing, firms are looking for ways to take advantage of IA to make their processes more efficient and drive innovation. After the artificial intelligence (AI) panel session at last year‘s conference, the DIA RIM Reference Model Working Group decided there was enough momentum around AI in the industry to establish an AI topic team. In this session, we will share the work that this team has been doing to date and upcoming plans to increase awareness and understanding of the various IA technologies, key problems in regulatory that they can potentially solve, potential solutions and best practices.

In this session, we will provide a high-level overview of what the various IA technologies are and how each of them can best be used to benefit Regulatory, what some key regulatory problems or use cases are that they can solve and some thoughts on potential solutions. Additionally, we will share examples of how sponsors are beginning to adopt IA, provide an industry point of view on IA usage and an understanding of how these tools can be validated in your Regulatory ecosystem.

Learning Objective :
  • Share work to date and upcoming plans for the following AI-oriented industry teams: DIA RIM Reference Model AI Topic Team, and Pharma RPA group
  • Describe the various types of intelligent automation (IA) technologies and how they can solve key regulatory problem areas or use cases
  • Establish a comprehensive data reuse strategy
  • Discuss regulatory IA usage at Janssen and Roche and provide an industry viewpoint on IA solutions and how to validate them


Cary  Smithson, MBA


Cary Smithson, MBA

Leapahead Solutions, Inc., United States

Managing Partner

Teresa  Eastwood-Kiefer


Teresa Eastwood-Kiefer

Roche, Switzerland

Global Lead, Regulatory Submission Management

Karin  Schneider, MLIS, MS


Karin Schneider, MLIS, MS

Johnson & Johnson Innovative Medicines, United States

Associate Director

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