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Introduction to MedDRA ® (Medical Dictionary for Regulatory Activities) MedDRA ® is a registered trademark of the International Federation of Pharmaceutical.

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Presentation on theme: "Introduction to MedDRA ® (Medical Dictionary for Regulatory Activities) MedDRA ® is a registered trademark of the International Federation of Pharmaceutical."— Presentation transcript:

1 Introduction to MedDRA ® (Medical Dictionary for Regulatory Activities) MedDRA ® is a registered trademark of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)

2 MSSO-DI ©2005 Northrop Grumman Corporation. All Rights Reserved. 2 What is MedDRA? Med = Medical D = Dictionary for R = Regulatory A = Activities

3 MSSO-DI ©2005 Northrop Grumman Corporation. All Rights Reserved. 3 Objectives for MedDRA Development An international multi-lingual terminology Standardized communication between industry and regulators Support of electronic submissions Application through all phases of the development cycle To provide:

4 MSSO-DI ©2005 Northrop Grumman Corporation. All Rights Reserved. 4 Objectives for MedDRA Development (cont) Classification for a wide range of clinical information Support for multiple medical product areas A terminology that saves time, resources, and money To provide (cont):

5 MSSO-DI ©2005 Northrop Grumman Corporation. All Rights Reserved. 5 MedDRA Definition MedDRA is a clinically-validated international medical terminology used by regulatory authorities and the regulated biopharmaceutical industry. The terminology is used through the entire regulatory process, from pre-marketing to post-marketing, and for data entry, retrieval, evaluation, and presentation.

6 MSSO-DI ©2005 Northrop Grumman Corporation. All Rights Reserved. 6 MedDRA Hierarchy System Organ Class (SOC) High Level Group Term (HLGT) High Level Term (HLT) Preferred Term (PT) Lowest Level Term (LLT)

7 MSSO-DI ©2005 Northrop Grumman Corporation. All Rights Reserved. 7 System Organ Classes Blood and lymphatic system disorders Cardiac disorders Congenital, familial and genetic disorders Ear and labyrinth disorders Endocrine disorders Eye disorders Gastrointestinal disorders General disorders and administration site conditions Hepatobiliary disorders Immune system disorders Infections and infestations Injury, poisoning and procedural complications Investigations Metabolism and nutrition disorders Musculoskeletal and connective tissue disorders Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nervous system disorders Pregnancy, puerperium and perinatal conditions Psychiatric disorders Renal and urinary disorders Reproductive system and breast disorders Respiratory, thoracic and mediastinal disorders Skin and subcutaneous tissue disorders Social circumstances Surgical and medical procedures Vascular disorders

8 MSSO-DI ©2005 Northrop Grumman Corporation. All Rights Reserved. 8 Each MedDRA term assigned an 8-digit numeric code The code is non-expressive Codes can fulfill a data field in various electronic submission types (e.g., E2b) Initially assigned alphabetically by term starting with –New terms are assigned sequentially Supplemental terms are assigned codes MedDRA Codes

9 MSSO-DI ©2005 Northrop Grumman Corporation. All Rights Reserved. 9 Terms are being renamed –When terms are renamed, the code number is reused for the renamed term –Renaming has been done for spelling errors, hyphenation, and parenthesis changes When HLT or HLGT terms are removed from the terminology, they are deleted – NOT moved to the LLT level and made non-current MedDRA Codes (cont)

10 MSSO-DI ©2005 Northrop Grumman Corporation. All Rights Reserved. 10 Non-Current Terms Non-current terms are flagged at the LLT level within MedDRA Not recommended for continued use Retained within the terminology to preserve historical data for retrieval and analysis Terms very vague, ambiguous, out- dated, truncated, or misspelled Terms derived from other terminologies that do not fit MedDRA rules

11 MSSO-DI ©2005 Northrop Grumman Corporation. All Rights Reserved. 11 A Multi-Axial Terminology Multi-axial = the representation of a medical concept in multiple SOCs Allows terms to be grouped by different classifications Allows retrieval and presentation via different data sets Allows an automatic assignment of predefined term groupings

12 MSSO-DI ©2005 Northrop Grumman Corporation. All Rights Reserved. 12 SOC = Respiratory, thoracic and mediastinal disorders HLGT = Respiratory tract infections HLT =Viral upper respiratory tract infections HLT = Influenza viral infections HLGT = Viral infectious disorders SOC = Infections and infestations PT = Influenza A Multi-Axial Terminology (cont)

13 MSSO-DI ©2005 Northrop Grumman Corporation. All Rights Reserved. 13 PT = Diabetes mellitus HLT = Diabetes mellitus (incl subtypes) HLGT = Glucose metabolism disorders (incl diabetes mellitus) A Multi-Axial Terminology (cont) SOC = Metabolism and nutrition disorders SOC = Endocrine disorders

14 MSSO-DI ©2005 Northrop Grumman Corporation. All Rights Reserved. 14 MSSO Contacts Mail MSSO VAR1/MSSO Sunset Hills Road Reston, VA USA Telephone –Toll-free Worldwide (AT&T) Fax –

15 MSSO-DI ©2005 Northrop Grumman Corporation. All Rights Reserved. 15 MSSO Contacts (cont) To Subscribe by – –Website click on subscribing to MedDRA Web page –www.meddramsso.com Products and Services –Toll-free Worldwide (AT&T)

16 MSSO-DI ©2005 Northrop Grumman Corporation. All Rights Reserved. 16 MSSO Contacts (cont) Help Desk Phone International AT&T Toll Free: Direct Dial (USA):

17 MSSO-DI ©2005 Northrop Grumman Corporation. All Rights Reserved. 17 Acknowledgements COSTART Thesaurus Fifth Edition Copyright 1995 US Food and Drug Administration (FDA) Hoechst Adverse Reaction Terminology System (HARTS) © 1992 Aventis Pharma ICD-9-CM International Classification of Diseases, Ninth Revision, Clinical Modification, Copyright © 1998 Medicode, Inc.

18 MSSO-DI ©2005 Northrop Grumman Corporation. All Rights Reserved. 18 Acknowledgements (cont) Japanese Adverse Reaction Terminology (J-ART), is a product of the Japanese Ministry of Health, Labour and Welfare (MHLW) MedDRA ® is a registered trademark of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) WHO Adverse Reaction Terminology (WHO-ART), Copyright World Health Organization Collaborating Centre for International Drug Monitoring


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