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 & 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
- 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
- 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 https://www.researchandmarkets.com/r/70ulek