Regulatory medical writing

Learn how you handle challenges when you write or revise regulatory documents
No available dates

On location

English

17,350 DKK ex VAT
(app. 2,333 EUR ex VAT)
50% DISCOUNT FOR PUBLIC INSTITUTIONS

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.

Hi! 

Do you need help choosing the right course? 

We are ready to help you at +45 39 27 60 60 or contact@atriumcph.com 

Stay tuned with Atrium's newsletter 

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
Read more

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

  1. The key criteria to evaluate the quality of document communication
  2. The characteristics of an effective summary and the principles of concise writing
  3. How regulatory authorities read documents and how to write from the reader’s perspective at paragraph and sentence level
  4. What ‘the architecture of the argument’ means why this is important
  5. Tools and best practices to help plan, organize and write documents

What your company will get

  1. An employee with an enhanced understanding of the regulatory readers
  2. An employee who knows how to best meet regulatory requirements in an efficient way
  3. An employee who can contribute to improved documentation and more efficient review processes
  4. A professional who knows how to pick “the low hanging fruits” when it comes to improving medical writing

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.

You may also be interested in these courses

WANT TO KNOW MORE or need help?

Contact Client Manager Christina Spangsberg at +45 39 15 09 22

Send me a message