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Successful Medical Writing Seminar: Writing the content of the Clinical Study Report and applying the ICH E3 Guideline (London, United Kingdom - May 21-23, 2019)

DUBLIN, May 28, 2019 /PRNewswire/ -- The "Successful Medical Writing" conference has been added to's offering

Success in the pharmaceutical industry depends on the speed and efficiency of new drug approvals. This process largely relies on the quality of documentation submitted to the regulatory authorities, and a high standard of medical writing plays a vital role in ensuring success. This intensive practical medical writing course will benefit participants by enabling them to achieve this standard.

Aims and objectives

This intensive and interactive course combines lectures with practical exercises to provide a thorough introduction to the basics of medical writing that goes beyond the usual overview' courses. It will provide in-depth training in general writing and data presentation skills, and specifically in the kind of documents most frequently encountered in clinical research. Participants will learn both the theoretical and practical aspects of writing for regulatory authorities as well as the sensible use of international guidelines, standards and useful writing tips. Many illustrative examples will be used, drawn from the seminar leaders' wide experience of the pharmaceutical industry

Topics to be covered:

  • Gain practical advice to help enhance your writing skills
  • Writing the content of the Clinical Study Report and applying the ICH E3 Guideline
  • Develop your confidence in using statistics
  • Improve your data presentation skills with use of tables, graphs and flowcharts
  • Best practice to ensure you are kind to your reader

Who Should Attend:

This three-day course will be of interest to all those in the pharmaceutical industry who prepare research reports and documentation intended for regulatory authorities. Although the focus of the seminar is on clinical research documentation, many of the principles will also apply to other types of reports, including pre-clinical, CMC and veterinary documentation. The practical training will benefit not only those new to medical writing, but also those wishing to perfect their existing writing skills, including full-time medical writers and those who only occasionally write research documentation or regulatory submissions.


Programme Day One

Overview of Writing: Substantive & Technical Aspects

Improving readability - being kind to your reader

  • Punctuation specifics
  • Verb force and tense

Paragraphing and word order

  • Verbosity
  • Prepositions
  • Abbreviations
  • Text review, edit or rewrite

The Clinical Study Report (CSR)

  • General aspects
  • CSR templates
  • Opening chapters and synopsis
  • Investigational plan
  • Results - efficacy
  • Results - safety

More on the CSR and improving readability

Programme Day Two

CSR - Post-scripts: After the Main Text

  • Quality Control

Designing Tables

  • Table types
  • Elements of table design

Statistics for Medical Writers

  • Statistical basis of clinical studies
  • Misuse of p-values
  • Primary vs. secondary efficacy variables
  • Developing confidence in confidence intervals

Programme Day Three

The Common Technical Document

  • Introduction to clinical submission dossiers
  • Purpose and types of clinical summary documents
  • Writing the clinical overview and the clinical summary
  • Recent regulatory developments: really a common technical document?

Writing publications, including abstracts

  • Publications vs clinical study reports
  • Consort guidelines for reporting randomised controlled clinical trials
  • Maximising acceptance
  • Understanding instructions to authors

Advanced data presentation

  • Graphs, plots, charts and diagrams
  • Design and use of flowcharts

Just how perfect does your document have to be?

  • How important is perfect' grammar?
  • Suiting language to the audience
  • Is word order really important?
  • Quality vs time

Final checks - proofreading Writing tips and tools

Working with co-authors and reviewers

General discussion and end of course

For more information about this conference visit

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