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ICH E2A GUIDELINE

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THIS IS ICH E2A GUIDELINE -CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING

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ICH E2A GUIDELINE

  1. 1. ICH GUIDELINES<br />HARMONISING FOR BETTER HEALTH<br /> BY<br /> T.SATHISH KUMAR<br /> PHARMACOVIGILANCE<br />
  2. 2. CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING (E2A) <br />
  3. 3. CONTENTS<br /><ul><li> INTRODUCTION
  4. 4. DEFINITIONS AND TERMINOLOGY
  5. 5. STANDARDS FOR EXPEDITED REPORTING
  6. 6. DATA ELEMENTS FOR EXPEDITEDREPORTS</li></li></ul><li>INTRODUCTION<br /><ul><li>Ensure uniform Good Clinical Practice standards in drug developmental stage
  7. 7. The development of standard definitions and terminology for key aspects of clinical safety reporting
  8. 8. For appropriate mechanism for handling expedited (rapid) reporting, in the investigational phase</li></li></ul><li>DEFINITIONS AND TERMINOLOGY ASSOCIATED WITH CLINICAL SAFETY EXPERIENCE<br />Adverse Event (or Adverse Experience)<br />Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment<br />
  9. 9. DEFINITIONS AND TERMINOLOGY ASSOCIATED WITH CLINICAL SAFETY EXPERIENCE<br /> Adverse Drug Reaction (ADR)<br />In the pre-approval clinical experience :<br />All noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions<br />
  10. 10. DEFINITIONS AND TERMINOLOGY ASSOCIATED WITH CLINICAL SAFETY EXPERIENCE<br />Expected Adverse Drug Reaction<br />An adverse reaction, the nature or severity of which is consistent with the applicable product information (Investigator's Brochure)<br /> Unexpected Adverse Drug Reaction<br />An adverse reaction, the nature or severity of which is not consistent with the applicable product information (Investigator's Brochure)<br />
  11. 11. DEFINITIONS AND TERMINOLOGY ASSOCIATED WITH CLINICAL SAFETY EXPERIENCE<br />Serious Adverse Event or reaction<br /> A serious adverse event (experience) or reaction is any untoward medical occurrence that at any dose<br /> - results in death<br /> - is life-threatening<br /> - requires inpatient hospitalisation or prolongation of existing hospitalisation<br /> - results in persistent or significant disability/incapacity<br /> - congenital anomaly/birth defect<br />
  12. 12. STANDARDS FOR EXPEDITED REPORTING<br />What Should be Reported<br /><ul><li>Single Cases of Serious, Unexpected ADRs
  13. 13. Reports from spontaneous sources and from any type of clinical or epidemiological investigation
  14. 14. Source should be specified always
  15. 15. Reasonable suspected causal relationship to the medicinal product qualify as ADRs</li></li></ul><li>STANDARDS FOR EXPEDITED REPORTING<br />Other Observations<br /><ul><li>lack of efficacy
  16. 16. Increase in the rate of occurrence of an expected serious ADR
  17. 17. Newly completed animal study </li></li></ul><li>STANDARDS FOR EXPEDITED REPORTING<br />Reporting Time Frames<br />Fatal or Life-Threatening Unexpected ADR<br /><ul><li>Should be notified as soon as possible but no later than 7 calendar days after first knowledge by the sponsor
  18. 18. Complete report as possible within 8 additional calendar days</li></li></ul><li>STANDARDS FOR EXPEDITED REPORTING<br /> Reporting Time Frames<br />All Other Serious, Unexpected ADRs <br /><ul><li>No later than 15 calendar days after first knowledge by the sponsor</li></li></ul><li>STANDARDS FOR EXPEDITED REPORTING<br /> Minimum criteria for reporting<br /><ul><li>An identifiable patient
  19. 19. Suspect medicinal product
  20. 20. An identifiable reporting source
  21. 21. And an event or outcome (SUSAR)</li></li></ul><li>STANDARDS FOR EXPEDITED REPORTING<br />How to Report<br /><ul><li>The CIOMS-I is standard for expedited adverse event reporting
  22. 22. Reports must be sent to regulatory or other official parties requiring them in countries where the drug is under development
  23. 23. Informing investigators and ethics committees/ institutional review boards of new safety information</li></li></ul><li>KEY DATA ELEMENTS FOR EXPEDITEDREPORTS OF SERIOUS ADVERSE DRUG REACTIONS<br />Patient Details<br /><ul><li>Initials
  24. 24. Other relevant identifier (clinical investigation number, for example)</li></ul> - Gender<br /> - Age and/or date of birth<br /> - Weight<br /> - Height<br />
  25. 25. KEY DATA ELEMENTS FOR EXPEDITEDREPORTS OF SERIOUS ADVERSE DRUG REACTIONS<br />Suspected Medicinal Product(s)<br /><ul><li>Brand name as reported
  26. 26. International Non-Proprietary Name (INN)
  27. 27. Indication(s) for which suspect medicinal product
  28. 28. Dosage form and strength
  29. 29. Route of administration</li></ul>Other Treatment(s)<br /><ul><li>concomitant medicinal products</li></li></ul><li>KEY DATA ELEMENTS FOR EXPEDITEDREPORTS OF SERIOUS ADVERSE DRUG REACTIONS<br />Details of Suspected Adverse Drug Reaction<br /><ul><li>Start date (and time) of onset of reaction
  30. 30. Stop date (and time) or duration of reaction
  31. 31. Dechallenge and rechallenge information
  32. 32. Outcome</li></li></ul><li>KEY DATA ELEMENTS FOR EXPEDITEDREPORTS OF SERIOUS ADVERSE DRUG REACTIONS<br /> Other details<br /><ul><li> Details on Reporter of Event
  33. 33.  Administrative and Sponsor/Company Details</li></li></ul><li>
  34. 34. THANKYOU<br />

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