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Gaylord Palms Resort & Convention Center

Mar 21, 2016 1:00 PM - Mar 23, 2016 4:30 PM

6000 West Osceola Parkway, Kissimmee, FL 34746

Medical Affairs and Scientific Communications 2016 Annual Forum

Cross-functional forum spotlights topics related to medical communication, medical science liaison, medical call center, and medical writing professionals.

Session 4 Track D: Best Practices for Regulatory Quality Review

Session Chair(s)

Michael  Church, MA

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

Managing the Quality Review Process

Michael Church, MA

Syneos Health, United States

Senior Director, Medical Writing

Victoria  Vick

Quality Review of Regulatory Documents – Processes and Outcomes

Victoria Vick

inVentiv Health, United States

Medical Writer II

Ann  Winter-Vann, PhD

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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