Introduction to Effective Medical Writing

This course is valuable to those who write or review documentation in support of clinical trials and regulatory submissions. It will also benefit professionals who prepare or review articles and abstracts about therapeutic products in any phase of development for professional publication. The course is particularly helpful for those new to the discipline and wish to understand the scope of medical writing. Typical attendees include medical writers, reviewers of medical documents, clinical research managers and associates, regulatory affairs professionals, project physicians and medical monitors.

Learning Objectives

Upon completion of this course you will understand

• What medical writing encompasses
• How to write documents that meet the company’s goals and objectives
• Why publishing is an essential part of therapeutic product position
• How to write an abstract or manuscript
• How to control sentence structures for precise delivery of data
• How to increase clarity and effectiveness through tone and voice
• How create effective data displays
• The role of the writer in producing and issuing documents
• How to overcome Writer’s Block
• How to produce documents within controlled timelines
• The best ways to manage the review process
• What kind of feedback is useful to other writers
• How to reach concurrence in the review process

Course Description

High-quality medical writing, which has a multi-million dollar impact on a company’s financial performance, can prevent the need for additional clinical trials which are often required because of unclear communication and poorly written documents. Good medical writing can lead to optimal product labeling, allowing successful product promotions and maximization of advertising claims.

Well written submission documentation can decrease the length of the product marketing approval process and increase the amount of time a product can be sold under patent protection. This course provides an overview of how to present product information clearly and concisely for the targeted audience. Hands-on exercises reinforce the course content.

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COURSE AGENDA

DAY ONE

Fundamentals of Good Medical Writing

• Introductions and course agenda
• The scope of medical writing
• Qualities of effective medical writing
• The writer’s role
• Assessing the audience
• Identifying and placing key messages

Overview of the Regulatory, Marketing, and Drug Promotion Processes

• How the regulations drive medical writing
• INDs/IDEs
• Clinical protocols, amendments, and study reports
• IBs and product labels
• NDAs/BLAs/PMAs
• Annual reports
• Product labeling
• Abstracts and posters for scientific meetings
• Manuscripts for publication in scientific journals

The Clinical Study Report

• Sections of a clinical study report
• Templates and boilerplate text
• Purpose of each section
• Tips on writing each section of the clinical study report

Writing for Publication

• Publishers’ requirements for manuscripts
• Standard manuscript elements: abstract, introduction, materials and methods, results, and discussion
• Abstracts and posters for professional meetings
• Preparation, review, submission, acceptance, revision, publication

DAY TWO

Controlling the Sentence

• Objectivity and tone
• Fundamentals of sentence construction
• Controlling voice for readability
• Select punctuation

Achieving Flow and Cohesiveness

• Writing effective paragraphs
• Using transitions
• Using effective data displays
• Using style guides for consistent medical writing
• Overcoming writer’s block and finding time to write

Managing the Review Process

• Charting the process flow
• Establishing metrics for managing regulatory submissions
• Putting a disclosure process in place
• Effective review practices
• Managing disparate comments from reviewers
• Reaching concurrence