Indroduction

The Medical Dictionary for Regulatory Activities (MedDRA) Terminology is the international medical terminology developed under the auspices of the International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. This guide describes the development, scope, and structure of the terminology.

MedDRA Solution 2008 is the leading software for MedDRA coding. MedDRA Solution 2008 software provides an easy-to-use interface for determination of the appropriate MedDRA terminology, which is a crucial part of safety assessment in clinical trials.

MedDRA Solution 2008 is an excellent tool for inexpensively training coders how to use MedDRA, performing manual and spreadsheet autoencoding, and creating a coding thesaurus for use by your clinical database. MedDRA Solution 2008 provides a graphical display of the MedDRA terminology, which has the ability to drill down to the lowest level terms. In addition, MedDRA Solution 2008 provides a very flexible search with correcting coding capability. MedDRA Solution 2008 is a desktop system that is cost-effective, which can meet timely solution for MedDRA coding needs.

Developed Based on MSSO

The Maintenance and Support Services Organization (MSSO) serves as the repository, maintainer, and distributor of MedDRA as well as the source for the most up-to-date information regarding MedDRA and its application within the biopharmaceutical industry and regulators. MedDRA subscribers submit proposed changes to the terminology. The MSSO includes a group of internationally based physicians who review all proposed subscriber changes and provide a timely response directly to the requesting subscriber.