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MedDRA Terminology -  a brief overview and update Andrea Neal, DMD, MPH Office of Post-Marketing Drug Risk Assessment Cent...
MedDRA Terminology <ul><li>ICH Harmonized Medical Terminology for Regulatory Purposes </li></ul><ul><li>An International M...
Current Situation Makes Exchange of Information Difficult <ul><li>Research Institutions and Practitioners </li></ul><ul><u...
Benefits of the Standard Terminology <ul><li>Improve regulatory communications between all involved parties </li></ul><ul>...
Benefits of the Standard Terminology <ul><li>Decrease submission time for INDs/NDAs </li></ul><ul><li>Improve product labe...
ICH guiding principles <ul><li>Build from existing terminologies to maximize compatibility </li></ul><ul><li>Focus on inte...
Terminologies Included <ul><li>MCA Medical Terminology </li></ul><ul><li>COSTART (5th ed.) </li></ul><ul><li>WHO-ART (96:4...
MedDRA Terminology <ul><li>Progression from version 1.0 to version 2.0 </li></ul><ul><li>Same 5-level hierarchical structu...
 
Scope of MedDRA <ul><ul><li>Diseases </li></ul></ul><ul><ul><li>Diagnoses </li></ul></ul><ul><ul><li>Signs </li></ul></ul>...
Scope of MedDRA (cont.) <ul><ul><li>Therapeutic indications </li></ul></ul><ul><ul><li>Investigation names & qualitative r...
Scope of possible, future expansion: <ul><li>drug /product terminology </li></ul><ul><li>equipment / device / diagnostic p...
Use throughout regulatory cycle <ul><li>Clinical Studies </li></ul><ul><li>Adverse Event/Reaction Reporting </li></ul><ul>...
Adverse Event Reporting in CDER - changing environment <ul><li>Rapidly growing # reports - 200,000 + / yr. </li></ul><ul><...
MedDRA Implementation: FDA <ul><li>MedDRA implemented Nov. ‘97  </li></ul><ul><li>Launch of AERS (Adverse Event Reporting ...
ANPRM Issued 11/5/98 <ul><li>For Electronic ADR Reporting </li></ul><ul><li>To Implement: </li></ul><ul><ul><li>ICH M1 (Me...
ANPRM (cont.) <ul><li>Comments specifically solicited regarding: </li></ul><ul><ul><li>whether exemptions should be grante...
Next Steps <ul><li>Continue implementation on post-market side </li></ul><ul><li>Prepare NPRM for Electronic ADR Reporting...
Web Sites to Check Out <ul><li>http://www.fda.gov </li></ul><ul><li>http://www.fda.gov/cder </li></ul><ul><li>http://www.f...
<ul><li>WWW.CRTUTOR.COM </li></ul>
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Med ra terminology

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MedDRA - the Medical Dictionary for Regulatory Activities - is a medical terminology used to classify adverse event information associated with the use of biopharmaceuticals and other medical products (e.g., medical devices and vaccines). Coding these data to a standard set of MedDRA terms allows health authorities and the biopharmaceutical industry to more readily exchange and analyze data related to the safe use of medical products.

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Med ra terminology

  1. 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
  2. 2. MedDRA Terminology <ul><li>ICH Harmonized Medical Terminology for Regulatory Purposes </li></ul><ul><li>An International Medical Terminology (IMT) </li></ul><ul><li>Multi-axial terminology built upon 5-level Hierarchical Structure </li></ul>
  3. 3. Current Situation Makes Exchange of Information Difficult <ul><li>Research Institutions and Practitioners </li></ul><ul><ul><li>create multiple submissions in various terminologies </li></ul></ul><ul><li>Industry / CROs </li></ul><ul><ul><li>receive reports in various terminologies </li></ul></ul><ul><li>FDA report evaluators </li></ul><ul><ul><li>receive submissions coded in various terminologies </li></ul></ul>
  4. 4. Benefits of the Standard Terminology <ul><li>Improve regulatory communications between all involved parties </li></ul><ul><li>Facilitate consistent coding and decrease information loss, thereby enhancing quality review </li></ul><ul><li>Decrease time spent by reviewers on data normalization </li></ul><ul><li>(cont…) </li></ul>
  5. 5. Benefits of the Standard Terminology <ul><li>Decrease submission time for INDs/NDAs </li></ul><ul><li>Improve product labeling </li></ul><ul><li>Facilitate shift to electronic submissions - pre & post </li></ul><ul><li>Improve epidemiological study on global scale </li></ul>
  6. 6. ICH guiding principles <ul><li>Build from existing terminologies to maximize compatibility </li></ul><ul><li>Focus on international community needs </li></ul><ul><li>Ensure worldwide use through collaboration and participation in development </li></ul><ul><li>Ensure mechanisms and structures to enable translation into many languages </li></ul><ul><li>Ensure long-term maintenance </li></ul>
  7. 7. Terminologies Included <ul><li>MCA Medical Terminology </li></ul><ul><li>COSTART (5th ed.) </li></ul><ul><li>WHO-ART (96:4) </li></ul><ul><li>J-ART (1996) </li></ul><ul><li>ICD-9 </li></ul><ul><li>ICD-9-CM (4th revision) </li></ul><ul><li>HARTS (release 2.2) </li></ul>
  8. 8. MedDRA Terminology <ul><li>Progression from version 1.0 to version 2.0 </li></ul><ul><li>Same 5-level hierarchical structure </li></ul><ul><li>Thousands of additional terms </li></ul><ul><li>Complete re-write of several SOCs </li></ul>
  9. 10. Scope of MedDRA <ul><ul><li>Diseases </li></ul></ul><ul><ul><li>Diagnoses </li></ul></ul><ul><ul><li>Signs </li></ul></ul><ul><ul><li>Symptoms </li></ul></ul><ul><ul><li>(cont…..) </li></ul></ul>
  10. 11. Scope of MedDRA (cont.) <ul><ul><li>Therapeutic indications </li></ul></ul><ul><ul><li>Investigation names & qualitative results </li></ul></ul><ul><ul><li>Medical & surgical procedures </li></ul></ul><ul><ul><li>Medical, social, family history </li></ul></ul>
  11. 12. Scope of possible, future expansion: <ul><li>drug /product terminology </li></ul><ul><li>equipment / device / diagnostic prod. </li></ul><ul><li>study design </li></ul><ul><li>patient demographic terms </li></ul><ul><li>device failure </li></ul><ul><li>population qualifiers (i.e. rare, frequent) </li></ul><ul><li>descriptors of severity </li></ul>
  12. 13. Use throughout regulatory cycle <ul><li>Clinical Studies </li></ul><ul><li>Adverse Event/Reaction Reporting </li></ul><ul><li>Regulatory Submissions </li></ul><ul><li>Regulated Product Information </li></ul>
  13. 14. Adverse Event Reporting in CDER - changing environment <ul><li>Rapidly growing # reports - 200,000 + / yr. </li></ul><ul><li>Faster review cycle </li></ul><ul><li>More complex pharmaceuticals </li></ul><ul><li>Aging population using more pharmaceuticals </li></ul>
  14. 15. MedDRA Implementation: FDA <ul><li>MedDRA implemented Nov. ‘97 </li></ul><ul><li>Launch of AERS (Adverse Event Reporting System) - January ‘98 </li></ul><ul><li>All Adverse Event Reports entered to database coded in MedDRA </li></ul>
  15. 16. ANPRM Issued 11/5/98 <ul><li>For Electronic ADR Reporting </li></ul><ul><li>To Implement: </li></ul><ul><ul><li>ICH M1 (MedDRA) </li></ul></ul><ul><ul><li>ICH M2 (Electronic Transmission Standards) </li></ul></ul><ul><ul><li>ICH E2B (Safety Report Data Elements) </li></ul></ul><ul><li>Goal of Paperless Environment by 2002 </li></ul>
  16. 17. ANPRM (cont.) <ul><li>Comments specifically solicited regarding: </li></ul><ul><ul><li>whether exemptions should be granted </li></ul></ul><ul><ul><ul><li>if so, their basis </li></ul></ul></ul><ul><ul><li>cost benefits / cost burdens </li></ul></ul><ul><ul><li>timeframes for implementing requirement </li></ul></ul><ul><li>Comments received and being considered </li></ul>
  17. 18. Next Steps <ul><li>Continue implementation on post-market side </li></ul><ul><li>Prepare NPRM for Electronic ADR Reporting </li></ul><ul><li>Lend CDER/CBER experience to the implementation of MedDRA on pre-market processes </li></ul>
  18. 19. Web Sites to Check Out <ul><li>http://www.fda.gov </li></ul><ul><li>http://www.fda.gov/cder </li></ul><ul><li>http://www.fda.gov/cder/aers/index.htm </li></ul><ul><li>http://www.fda.gov/medwatch </li></ul><ul><li>http://www.meddramsso.com </li></ul>
  19. 20. <ul><li>WWW.CRTUTOR.COM </li></ul>

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