The terminology is used through the entire regulatory process, from pre-marketing to post-marketing, and for data entry, retrieval, evaluation, and presentation. To provide (cont): Classification for a wide range of clinical information Support for multiple medical product areas A terminology that saves time and resources 5Ħ MedDRA and the MSSO International support and development of terminology Foster use of MedDRA through communications and educational offerings “Custodians”, not owners, of the terminology JMO (partner organization for Japanese-language MedDRA) Governed by a Management Board (industry, regulators, multi-national, other interested parties) 6 6ħ MedDRA Definition MedDRA is a clinically-validated international medical terminology used by regulatory authorities and the regulated biopharmaceutical industry. Result of an ICH initiative (M1) To provide: An international multi-lingual terminology Standardized communication between industry and regulators Support of electronic submissions Application through all phases of the development cycle 4ĥ Objectives for MedDRA Development (cont) Introduction to MedDRA’s structure and scope Demonstration of MedDRA Desktop Browser Standardised MedDRA Queries (SMQs) Examples of NCI’s use of MedDRAģ What is MedDRA? Med = Medical D = Dictionary for R = Regulatory Presented by: Ann Setser, MSSO JMedDRA® is a registered trademark of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)Ģ Agenda Background of MedDRA Regulatory status of MedDRA 1 MedDRA® Overview NCI Vocabulary and Common Data Elements Workspace
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