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Session 8 Track C: Quality Documents - From Draft to Finalization
Session Chair(s)
Ann Winter-Vann, PHD
Senior Writer and Manager
Whitsell Innovations, Inc., United States
Quality regulatory documents don’t just happen; they are the result of careful planning that starts before the first words are drafted. Effective templates provide the correct structure for a document and prompt the authoring team to include relevant content that is well organized and easy to understand. With a solid template in hand, the lead writer drafts the document, working closely with the authoring team to define the important messages and clearly communicate the data. Finally, the Quality Control specialist ensures that the data are accurately presented and that the document follows a consistent style. In this session, we will present strategies and best practices for designing and using templates, drafting and reviewing documents, and performing Quality Control checks to ensure consistent quality in regulatory documents.
Learning Objective : At the conclusion of this session, participants should be able to:
• Describe how to design and use effective template documents
• Discuss ways to implement strategies to maintain quality while working with a team of contributors to write and review regulatory documents
• Assess the accurate presentation of data and consistent use of style in a regulatory document
Speaker(s)
Faculty
Jane Stephenson, PHD, MBA
Boehringer Ingelheim Pharmaceuticals, Inc., United States
Director, Medical Writing
Faculty
Ann Winter-Vann, PHD
Whitsell Innovations, Inc., United States
Senior Writer and Manager
Faculty
Cathy Serrano
Vertex Pharmaceuticals, United States
Senior Manager, Medical Writing Science Operations