Regulatory Submissions, Information, and Document Management Forum

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

Session Chair(s)

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)

Biopharmaceutical Case Study: Automating Health Authority Communications with Machine Learning

James Nichols

Phlexglobal - Now Cencora Pharmalex, United States

Chief Product Officer

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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