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Med ra terminology
- 1. MedDRA Terminology - a brief overview and update Andrea Neal, DMD, MPH Office of Post-Marketing Drug Risk Assessment Center for Drug Evaluation and Research www.crtutor.com
Editor's Notes
- Currently, there are a number of AE terminologies in use across the world. The Pharm. industry is becoming more and more global.
- in an attempt to achieve greater consistency should also serve the purpose of enable us to
- As the ICH M1 EWG began to develop the new IMT, first and foremost, the w/g was interestin in building… rather than the needs of individual countries or regions both collab and partic
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- Coding practices are extremely important. Need to closely evaluate the existing process (ours and Industry’s), identify best practices, and in improving the process we need to strive for reliability and consistency. Will be my responsibility to gather, prioritize, and suggest changes to the MSSO for FDA users.
- And now Debbie Yaplee of our staff will describe the pilot program that we are conducting to promote the move towards the electronic submission of AE reports.