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Did you ever wonder what reviewers look for in your regulatory submissions? This audio conference combines the results of two in-depth interviews regarding effective writing in regulatory submissions and with known effective writing techniques and practices. The interviews were with a previous FDA reviewer and a current reviewer for a large Notified Body. Both interviewees shared their reactions to the quality and effectiveness of the writing in the hundreds of submissions they have each reviewed.

Topics include: analyzing the audience, identifying topics, organizing the topics in a logical way, applying document design principles, establishing document management conventions, writing, and assessing the effectiveness of your writing.

This audio conference covers:

• Analyze your audience to adapt your writing to meet your audience’s informational needs.
• Identify topics that are meaningful to your audience and necessary for their understanding the purpose of your writing.
• Organize your ideas logically so that your audience can read and understand your writing with ease.
• Apply document design principles to maximize reading comprehension and simplify information search and retrieval. Write by applying practical tips and tricks that are known to make writing effective.
• Establish document management conventions to organize your file and directory structure and apply naming conventions that assist in revision control.
• Assess your writing for its effectiveness.

About the speaker:

Nancy Hoft is a Regulatory Affairs professional specializing in US and European submissions for a medical device company. As an active member of RAPS, Nancy served on the Nominating Committee for three years and recently completed a module on regulatory writing for an upcoming online course in the RAPS Online University program.

A professional writer since 1984, Nancy has won awards for her writing and web site designs. In 1991, Nancy set up her own consulting and training practice, promoting effective techniques for communicating with multilingual and multicultural audiences. Her course content and teaching style continues to win praise from students and workshop participants worldwide. Clients and past seminar sponsors have included Ford Motor Company, Siemens Medical Systems, Microsoft, Wal-Mart, Disney, McDonald's, the University of Washington, the University of California Extension, Eindhoven University of Technology in The Netherlands, and the World Health Organization in Switzerland. Nancy has a degree in English from the University of Connecticut, with post-graduate studies at Northeastern University, Michigan Technological University, the University of South Florida and the Summer Institute for Intercultural Communication.

Who should attend?

• Regulatory Affairs Professionals
• Medical Writers
• Clinical Directors
• Quality Assurance Managers
• Product Engineers
• Research and Development Managers