Introduction to benefit-risk assessment for medical writers
5:00 PM - 6:30 PM
This seminar targets medical writers not expert in the benefit-risk field. Objective is to provide our members with a good understanding of the importance of this concept (e.g. for regulatory submissions to the FDA and EMA, particularly in the context of the Clinical Summaries of Safety and Efficacy, and the Integrated Summaries of Safety and Efficacy) and show which role the medical writer plays in constructing the elements of the benefit-risk sections of regulatory dossiers.