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Virtual

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

(Eastern Standard Time)

Regulatory Submissions, Information, and Document Management Forum

On Demand 4 Track 3: Transformation of the Documentation World: What’s Here and What’s to

Session Chair(s)

Joanne  Malia, MS, MSc

Joanne Malia, MS, MSc

Director, Development Records Management

Regeneron Pharmaceuticals, United States

In our first presentation, we will demonstrate how leveraging artificial intelligence and machine learning can rapidly decrease the duration of time it takes to complete the due diligence process byleveraging machines to enhance the process allowing humans to focus on the results.
Our second presentation will discuss the need as new solutions are introduced of providing our stakeholders with the opportunity to be part of this change, to be heard, and to leverage their knowledge to co-create a sustainable future. Thus, we have established a feedback and change control process to aid in the development of mature and robust content solutions and to harness the collective experience of our medical writing group to advance our content strategy.
Lastly we will round out the session with our third presentation on a discussion involving the exploration of how metadata may assist the research process focusing on the use case of protocol amendments.

Learning Objective :
  • Understand ways to use AI more effectively to extract insight against data silos of a company you may be acquiring
  • Leverage AI to make better decisions about data migration and archiving
  • Describe mindsets and behaviours required to transition a content management platform
  • Discuss strategies for change management
  • Understand the ways metadata can enhance the research process specifically with protocol amendments

Speaker(s)

Bryan  Reynolds

Leveraging Artificial Intelligence To Simplify Due Diligence During The Merger And Acquisition Process

Bryan Reynolds

Docxonomy, United States

Founder & CEO

Deborah  Card, PhD

Content Management Transformation Journey - Preparing for Automation

Deborah Card, PhD

Roche, Canada

Regulatory Content Transformation Lead

Sharon  McErlean, MSc

Protocol Amendment Metadata Landscape Exploration

Sharon McErlean, MSc

Novartis, Ireland

Clinical Development & Analytics Associate Director

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