This workshop will present ways for medical writers to avoid missteps in interpreting safety data and optimize presentation and analysis of MedDRA® data. Exercises highlighting MedDRA's features and ICH "Points to Consider" principles will be given. **Due to workshop format, seating will be limited and will be available on a first come, first served basis. The Pennsylvania Convention Center has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive at workshops early in order to ensure seating. Please note, as a workshop with interactivity, this event will not be recorded.

Learning Objectives:
Recognize how to ask the right questions of MedDRA-coded data, eg, when to do a secondary SOC analysis
Describe how MedDRA's structure and characteristics affect data retrieval
Discuss how to review MedDRA coded data to understand the safety profile of a product.