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.
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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.
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
Course leader(s) & Lecturers
- Gregory CuppanCourse leaderOwner
McCulley/Cuppan Inc.
IS THIS COURSE FOR YOU?
The course is relevant if you want to optimize your medical writing for the regulatory reader – for example if you are a professional in clinical research and development from a sponsor, CRO or academia, and you are involved in medical writing in clinical trials projects and drug approval submissions.
What you will learn
- The key criteria to evaluate the quality of document communication
- The characteristics of an effective summary and the principles of concise writing
- How regulatory authorities read documents and how to write from the reader’s perspective at paragraph and sentence level
- What ‘the architecture of the argument’ means why this is important
- Tools and best practices to help plan, organize and write documents
What your company will get
- An employee with an enhanced understanding of the regulatory readers
- An employee who knows how to best meet regulatory requirements in an efficient way
- An employee who can contribute to improved documentation and more efficient review processes
- A professional who knows how to pick “the low hanging fruits” when it comes to improving medical writing
Course calendar
DAY 1
- Introduction
- Writing for different types of readers
- Through the looking glass: a brief trip inside the head of the regulatory agency reader
- What is a regulatory document?
- Electronic documents and how they are really read
- Document quality standards
- Why organization is so important to readability
- Group exercise on organization strategy
- Recap and feedback on session
DAY 2
- Introduction
- Fundamentals of human cognition: System 1 vs. System 2 readers
- Balancing precision in regulatory communication
- Thinking fast or slow - the distinct modes of decision making
- The law of small numbers
- Cognitive bias and intuitive judgement (with examples from actual submissions)
- Group exercise
- A dive into some regulatory submission scenarios
- Group exercise
- Best-practice document review
- Group exercise
- Recap and feedback on session
Registration
Registration deadline25. May 2022
Lersø Parkallé 101
2100 København Ø
Course information
Literature
Prior to the course you will get access to mandatory and optional readings via your personal Atrium log-in.
Please familiarize yourself with the mandatory readings before starting the course.
Prerequisites
To enroll in this course, you must have a relevant educational background at bachelor level and, as a minimum, 6-12 months of experience in reporting of clinical research or other equivalent qualifications. We assess all applicants individually upon registration. If you do not fulfill the requirements, you can still apply for the course if you have experience within clinical research or from academia that qualifies you to benefit from the training and enables you to participate actively during the course.
You can receive feedback on your own or your organization’s writing, as we encourage participants to share regulatory document examples with us in advance of the workshop. At a slower pace, we will go through and discuss these along with other examples from the industry, in the context of the presented theory. We will also discuss elements from the Trancelerate templates, CORE Reference and CDISC terminology, including topics such as estimands, reporting of protocol deviations, disclosure and transparency initiatives, and redaction friendly writing.
Examination
There is no exam for this course.
Course leader(s)
McCulley/Cuppan Inc.
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