Optimizing Medical Writing for the Regulatory Reader

Learn how you handle challenges when you write or revise regulatory documents

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3 days course

English

17.350,- DKK ex VAT
(app. 2.333,- EUR ex VAT)

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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

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

Registration quick facts

You can pay by credit card or by invoice. We charge the amount shortly after you register. If you cancel your registration more than 30 days prior to the course, you will receive a full refund. Read our cancellation policy.

Yes, if you experience any technical problems, please call us at + 45 39 27 60 60, or send us an email at contact@atriumcph.com

If you cancel your registration more than 30 days prior to the course, you will receive a full refund. If you get sick and cannot attend the course, you may hand over the seat to a colleague, who will then have to register for the course on our website prior to course start. If the registration is closed, please send us full name, email, phone and title of your colleague to bfl@atriumcph.com. Read our cancellation policy.

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WANT TO KNOW MORE ABOUT THIS COURSE?

Contact Client Manager Mette Ribergaard Rasmussen at +45 39 15 09 30

Send an email

 

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