Three Day Successful Medical Writing Online Training Course, October 4-6, 2021 - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "Successful Medical Writing Training Course" conference has been added to ResearchAndMarkets.com'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 a positive outcome. This intensive three-day medical writing course will help you to improve your skills and achieve this standard.

Aims and objectives

This event combines presentations from our expert faculty 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.

You 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 course leaders' wide experience of the pharmaceutical industry.

Who Should Attend:

The 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, 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.

Key Topics Covered:

Overview of writing: substantive and technical aspects

Improving readability - being kind to your reader

• Punctuation specifics
• Verb force and tense

The CSR

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

Statistics for medical writers

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

Writing the investigator's brochure

• ICH E6 guidance
• Organising multiple author contributions
• Project management
• Consistency within and between topics

CSR - postscripts: after the main text

Quality control

Designing tables

• Table types
• Elements of table design

More on the CSR and improving readability

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

For more information about this conference visit https://www.researchandmarkets.com/r/kq9ijb

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Laura Wood, Senior Press Manager
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