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Session 4 Track D: Best Practices for Regulatory Quality Review
Session Chair(s)
Michael Church, MA
Senior Director, Medical Writing, Syneos Health, United States
This session will examine the quality review process for regulatory documents. Best practices will be described for annotating, increasing the efficiency of the reviews, and ensuring the accuracy of the information. In addition, the session will look at the process from a management perspective: effective resourcing practices when faced with large projects and accelerated timelines, managing “rolling” reviews, and maintaining a process that minimizes the risk of audit findings.
Learning Objective : At the conclusion of this session, participants should be able to:
- Discuss best practices for completing a quality review of a regulatory document
- Describe the types of tools used in quality review
- Define a strategy for effective annotation
- Evaluate complex projects and formulate resourcing and timeline strategies
- Identify potential audit risks and what can be done to minimize the risks
Speaker(s)
Michael Church, MA
Senior Director, Medical Writing, Syneos Health, United States
Victoria Vick
Medical Writer II, inVentiv Health, United States
Ann Winter-Vann, PHD
Senior Writer and Manager, Whitsell Innovations, Inc., United States
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