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.
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
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
For more information about this conference visit https://www.researchandmarkets.com/research/wtb89h/three_day?w=4