Dublin, Oct. 31, 2023 (GLOBE NEWSWIRE) -- The "Successful Medical Writing - from Protocol to CTD" 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,CMCand 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:
Day One
Overview of writing: substantive and technical aspects
- Helping your reader
The Protocol
- Developing the protocol
- The most important clinical document?
The CSR
- General aspects
- CSR templates
- Content - results-independent text
- Content - patient information & efficacy
Day Two
Completing the CSR
- Content - safety & discussion
Improving readability, for example:
- Brief overview of punctuation specifics affecting readability
- Verb force
Designing tables for clinical documents
- Table types
- Elements of table design
More on improving readability, for example:
- Prepositions
- Abbreviations
Summary Documents
- Overview including abstracts and synopses
Day Three
The Common Technical Document
- Introduction to clinical submission dossiers
- Purpose & types of clinical summary documents
- Writing the clinical overview & the clinical summary
- Recent regulatory developments: really a common technical document?
Project Management
- Improving the process, for example considering:
- Timelines
- Document review
Quality aspects
- Just how perfect does your document need to be?
Final checks
- Proofreading: just a spell check?
Additional writing tips and tools
For more information about this conference visit https://www.researchandmarkets.com/r/gp1uc1
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