Medical Writing Fundamentals: How to Write Regulatory Documents April 2019

Apr 10, 2019
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Course Description

Medical writing has its own standard practices and idiosyncrasies. Knowing what to write, how to format, and how to navigate corporate processes can require a big learning curve. This web seminar will give learners an overview of writing practices, formatting, working with tables/figures, and communicating effectively. Practical applications of these skills will be described as they apply to writing all types of documents for submission to global regulatory authorities, including protocols, clinical study reports, investigator’s brochures, data management plans, statistical analysis plans, documents for modules in the Common Technical Document (CTD) format, and briefing books. Real-life examples of strategies for generating a great document by understanding the what and why of the different documents will also be presented.

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Learning Objectives

  • Review basic medical writing skills, including correct abbreviation practices, consistent captioning, and table generation
  • Utilize styles and templates
  • Describe style guides and their importance
  • Describe the communication process needed for document review and completion
  • Conduct a literature search
  • Apply these skills to all regulatory documents

Who Should Attend

  • New Medical Writers
  • Clinical Research Professionals (i.e., CRAs, Data Managers)
  • Statisticians
  • Study Coordinators
  • Document Signatories (i.e., Chief Medical Officers, Clinical Pharmacologists)
  • Personnel who review regulatory documents or are involved with investigator-sponsored studies

Instructor

Caroline Ritchie, Ph.D., M.B.A.

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.