Judy Harrison, M.D. is a Senior Medical Officer in the MedDRA Maintenance and Support Services Organization (MSSO) where she is involved in terminology development and training. Dr. Harrison has 20 years' experience in clinical research and is a member of the ICH M1 Points to Consider Working Group.
Dr. Cole holds a BA in biochemistry and a PharmD and is a Certified MedDRA Coder. She has held positions in hospital-based drug information, industry-based medical information, and drug safety. She managed the centralized medical coding group at Gilead Sciences, Inc. for 5 years.
Description
This workshop will provide an overview of coding safety data with MedDRAź. Participants will apply the key principles in the "MedDRAź Term Selection: Points to Consider" document by engaging in practical coding exercises in an interactive format. **Due to workshop format, seating will be limited and will be available on a first come, first served basis. 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: Describe how to code clinical safety data accurately and consistently with MedDRAź Apply the principles described in the ICH-endorsed "MedDRAź Term Selection: Points to Consider" document.