Medical Writing Fundamentals: How to Write Regulatory Documents

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Course Description

This 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 seminar will give learners a broad understanding of writing practices, formatting, working with tables and 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. In addition, real-life examples of strategies for generating a great document each time by understanding the what and why of the different documents will be presented.

Learning Objectives

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

Who Should Attend

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

Instructor

The course will be led by one of the following instructors:

Cheryl Vitow

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Course Outline

Day 1: 8:30 a.m. – 5:00 p.m.

  • Basic Skills: Industry standards for formatting, abbreviations, tables, figures, captioning, linking, fonts
  • Styles and Templates: How to make styles work for you, template generation and use
  • Style Guides: What are they? Why have one?
  • Literature Searches: Practical methods for completing a literature search, understanding when to do it
  • Communication: Keys to successful document review and finalization 

Interactive Activities

During the course, participants will:

  • Create a standard table applying correct medical writing practices
  • Perform an active literature search
  • Practice tips and shortcuts that medical writers use every day
  • Participate in a short exercise regarding application of the course materials to different types of documents or different types of development (i.e., drugs, biologics, devices, diagnostics)

Registration Fees  

Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.

Special rates are available for multiple attendees from the same organization.  Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.

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Accreditation Information

ACPE LogoBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 7 hours (0.7 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE# 0778-0000-15-025-L01-P. Released 3/15.

Hold this course at your company!

For more information, contact Naila Ganatra at (215) 413-2471.