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Successful Medical Writing Training Course
Success in the pharmaceutical industry depends on the speed and efficiency of new drug approvals and the quality of documentation submitted to the regulatory authorities. This intensive, practical medical writing course will benefit participants by enabling them to achieve this standard.
Details
Course overview
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.
Programme
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
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
Presenters
Barry Drees (More...)
Dr Barry Drees has a PhD in molecular biology and he is an experienced trainer of medical writers today. He graduated from the University of California Santa Barbara and the University of California San Francisco (USA), was president of the European Medical Writers Association, was editor-in-chief of the Journal of the European Medical Writers Association, and has been a Senior Medical Writer since 1989.
James Visanji (More...)
James holds a PhD in Medicine from the University of Manchester, Masters in Clinical Genetics from the University of Sheffield, Chartered Linguist status from the Chartered Institute of Linguists, and the European Medical Writers Association Nick Thompson Fellowship.
After postdoctoral work at Istituto Europeo di Oncologia, James started his medical writing career in 2006. Based in Frankfurt, he is currently Associate Director of Regulatory Services at Synchrogenix, and was previously Medical Writing Manager at Trilogy Writing, and Deputy Director of Medical Writing and Electronic Publishing at Accovion.
James focuses on clinical and regulatory documentation, in particular, submission dossiers and subsequent regulatory interactions. James has been training medical writers and physicians since 2012, and claims to get his biggest buzz from making the next generation of writers as effective as possible, as quickly as possible.
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27-29 Apr 2022 Live webinar |
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27-29 Apr 2022 Live webinar |
GBP 1,549 1,249 EUR 2,229 1,809 USD 2,524 2,056 Until 23 Mar 22* |
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to attend Live webinar |
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11-13 Jul 2022 Face-to-face, (venue not yet confirmed) |
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11-13 Jul 2022 Face-to-face (venue not yet confirmed) |
GBP 1,849 1,549 EUR 2,589 2,169 USD 2,884 2,416 Until 6 Jun 22* |
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to attend Face-to-face (venue not yet confirmed) |
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11-13 Oct 2022 Live webinar |
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11-13 Oct 2022 Live webinar |
GBP 1,549 1,249 EUR 2,229 1,809 USD 2,524 2,056 Until 6 Sep 22* |
Online registration unavailable: this date is nearing full capacity; please contact us to register. |
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Learn more about our face-to-face and webinar training formats.
* Note the early booking discount cannot be combined with any other offers or promotional code