At the moment there are no available dates for this course.
Summary
How do you know when “good” is good enough when it comes to regulatory documents? Establishing quality standards that drive success in clinical and regulatory communication involves everything from personal perceptions about “when good is good enough,” to interpretations of guidelines, and analysis of subjective reviewer or end-user comments on quality. In this course, we will dive into the topic quality of communication and find meaningful criteria that drive success for documents that instruct or report clinical research to an end-user.
It is essential to apply proper criteria for communication in medical writing, but it is equally important to understand that these criteria vary by document genre and by sections within documents. As a medical writer, you must be adaptive in your approach to plan, author, and revise documents. In this course, you will learn how to assess communication quality in your writing, as well as others’, by using the criteria: focus, logic, content, context, organization, presentation and language.
You will learn what tools and work practices you can apply to plan, organize, write and revise our documents, and how to use methods and tools that support the application of concepts in your day-to-day work. We will also explore why and how project management tools are important to your success as a medical writer.
This fast-paced course is designed to raise your level of attention to some critical “what,” “why,” and “how” questions that will improve your regulatory communication. The course is dynamic and interactive with class discussions, medical writing examples, and group exercises, so you will be able to put the theoretical concepts into practice.
Lecturers
Gregory Cuppan, Managing Principal of McCulley/Cuppan Inc., has spent 20+ years developing and delivering training and consulting in the pharmaceutical and life sciences industries and has provided training for 50+ pharmaceutical companies.
Thomas Mondrup, Principle Professional Medical Writer, LEO-Pharma A/S, Denmark, has worked as a medical writer since the start of the millennium. He has drug approval submission experience across five companies from biotech to big pharma.
Keywords
Medical writing
The regulatory reader
Effective communication
Strategic review
Industry guidance and resources
Tools, tricks and best practices in medical writing
The medical writer’s role as a facilitator of communication excellence