Successful Medical Writing (London, United Kingdom - October 15-17, 2018) - Product Image

Successful Medical Writing (London, United Kingdom - October 15-17, 2018)

  • ID: 4435947
  • Conference
  • Location: London, United Kingdom
  • 3 Days
  • Management Forum
  • Conference Dates: October 15-17, 2018
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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 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

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.

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

Please note, events may be cancelled due to commercial or organisational reasons. In this case Research and Markets will refund all registration fees which have already been paid. Research and Markets will not refund any charges arising from the participant having to cancel or re-book transportation or accommodation which he or she has arranged.

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Programme Day One

Overview of Writing: Substantive & Technical Aspects

  • The Clinical Study Report (CSR): General Aspects*

Punctuation Specifics

  • CSR Templates

Improving Readability – Being Kind to Your Reader

  • Verb force & Tense
  • Paragraphing & Word Order
  • Verbosity
  • Prepositions
  • Abbreviations

CSR: Opening Chapters & Synopsis

  • Investigational Plan
  • Results – Efficacy

More on Improving Readability Results – Safety

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

Writing the Investigator’s Brochure

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

Abstracts

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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.

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ADDRESS

London
United Kingdom

Venue to be announced shortly.

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