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Drug Safety for Medical Writers Part 1: Adverse Events and Concomitant Medications

Drug Development
Workshop profile:
This workshop is intended for people who are new to medical writing and who are involved in writing the safety sections of clinical study reports or related safety summaries.
This workshop is designed to give medical writers insight into the processes by which adverse event and concomitant medication data are generated and recorded during clinical trials and the subsequent handling of the data. On completion of the workshop package, participants should be confident in their approach to writing the adverse event and concomitant medication sections of documents relating to clinical trials.
The role of the medical writer in preparing summaries of safety data is to take a large amount of information and to present the most important points in a useful and understandable format. The challenge for the writer is to identify what is important and to answer the readers’ questions before they have been asked. The collection of clinical safety data on a drug begins at the clinical trial level. All safety summaries are built upon this starting point. The aim of the workshop is to bring the data to life so that the writer can present safety data that is interesting to the reader. It is not necessary for participants to attend both Part 1 and Part 2 of the workshop but the two parts provide a complete picture of the safety data that is usually collected in clinical trials and presented in study reports.