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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)
Managing the Quality Review Process
Michael Church, MA
Syneos Health, United States
Senior Director, Medical Writing
Quality Review of Regulatory Documents – Processes and Outcomes
Victoria Vick
inVentiv Health, United States
Medical Writer II
Drafting Regulatory Documents to Minimize Quality Review Findings
Ann Winter-Vann, PhD
Whitsell Innovations, Inc., United States
Senior Writer and Manager
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