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The format and preparation of clinical trial applications and submissions to the EU and US continues to evolve, and the consequences of this on medical writing, workflow and process will be presented. The impact of the Clinical Trial Directive and specific regional requirements on global organisations will also be discussed. The ad- vantages and challenges of medical writing outsourcing will be reviewed now that countries such as India are offering this service. The skills required in communication of safety data and in the presentation of information to patients will also be included.
Please Note: The day before this course, October 17, 2007 a one day workshop devoted to “Operational Interfaces - From Study Planning to Report” will be held. This special joint event was generated as a team effort amongst DIA’s Clinical Data Management, Statistics and Medical Writing SIACs (Special Interest Area Communities) to encourage interaction between the members of the key disciplines in the process of planning, conducting and reporting a clinical trial.
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