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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

Session 10 Track 3: From Question to Answer: How Automation can Improve Health Authority Communication

Session Chair(s)

Cindy  Chiu

Cindy Chiu

Senior Director, Regulatory Affairs Operations and Quality Management

Merck & Co., Inc., United States

This session will focus on the innovations being made with technology to address the need for compliance, quality and efficiency when handling health authority questions and communication. From original receipt and handling to responding with consistent information quickly, companies such as Merck and Phlexglobal are improving the end-to-end process with intelligent technologies.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Understand the importance of addressing HA Comms in an end-to-end fashion
  • Identify areas within their organization where there are opportunities for improvement for HA Comms
  • Better understand how modern technologies can be leveraged for greater overall performance
  • Assess the advantages of a Health Authority Response to Question central repository for specific use cases

Speaker(s)

James  Nichols

Biopharmaceutical Case Study: Automating Health Authority Communications with Machine Learning

James Nichols

Lorenz Life Sciences Group, United States

Director of Sales & Account Management

Leslie  Kitchen, BSN, RN

Response to Health Authority Questions (RTQ)

Leslie Kitchen, BSN, RN

Merck & Co., United States, United States

Senior Director Regulatory Innovation and Information Management

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