Effective Medical Writing and Transcription Event, 03.Feb.2025

Introduction

Course Objectives of  Medical Writing and Transcription

• Exploring the meaning of medical writing
• Learning how to write documents that meet the company’s goals and objectives
• Understanding the importance of publishing as an essential part of therapeutic product position
• Writing an abstract or manuscript 
• Creating effective data displays
• Understanding the role of the writer in producing and issuing documents
• Discussing the best ways to manage the review process
• Providing and receiving feedback in useful way
• Reaching concurrence in the review process

Course Outlines Medical Writing and Transcription

Day 1

Getting to Know Medical Writing

• The scope of medical writing
• Effective medical writing
• The writer's role
• Assessing the audience
• Identifying and placing key messages

• INDs/IDEs
• Clinical protocols and 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

• Using templates
• Purpose of each section
• Clarity and consistency in writing

• 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
• Identifying key information and paring the language

Day 3

Controlling the Sentence

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

Day 4

Achieving Flow and Cohesiveness

• Writing effective paragraphs
• Using transitions
• 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