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Ich gcp

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ich-gcp

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Ich gcp

  1. 1. ICH GCP
  2. 2. INTERNATIONAL COUNCIL ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE
  3. 3. INTRODUCTION • International ethical & scientific quality standard • For designing, conducting, recording & reporting trials • That involve participation of human subjects
  4. 4. Provides public assurance that • The rights, safety & wellbeing of the subjects are protected • clinical trial data is credible
  5. 5. OBJECTIVE • To provide unified standard for the European union, Japan & United states to facilitate the mutual acceptance of clinical data
  6. 6. HISTORY • NUREMBERG CODE-At the end of World war II • DECLARATION OF HELSINKI-1964 • BEECHER ARTICLE-1966 • TUSKEGEE STUDY-1932-1972 • BELMONT REPORT-1979 • ICH GCP-1996
  7. 7. INTERNATIONAL COUNCIL ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE • Created in April 1990 • Brussels • Final draft version presented & approved - 1996. • Current version dated January 1997
  8. 8. PRINCIPLES
  9. 9. WHO principles for GCP Principle 1 – Ethical Conduct • Research involving humans  Scientifically sound  In accordance with Declaration of Helsinki
  10. 10. Principle 2: Risk Identification • Foreseeable risks and discomforts and any anticipated benefit(s)  To be identified
  11. 11. • Research initiated only if anticipated benefit(s) outweigh the risks
  12. 12. Principle 3 Most important considerations Rights, Safety, and Well-being of trial subjects
  13. 13. Principle 4 • Nonclinical and clinical information • On investigational product • should be adequate
  14. 14. Principle 5: Protocol • Research  To be described in a –Clear, –Detailed, and –“Scientifically justified” protocol
  15. 15. Principle 5: Review by IEC/IRB • Research should receive independent (IEC/IRB) approval prior to initiation
  16. 16. Principle 6: Protocol Compliance • Research  Conducted in compliance with the approved protocol
  17. 17. Principle 7 Qualified Physician •Medical care given •Medical decisions taken •Responsibility of a qualified physician
  18. 18. Principle 8: Staff Qualifications • Each individual involved should be qualified by –Education, –Training, and –Experience
  19. 19. Principle 9: Informed Consent • To be obtained –From every subject –Prior to research participation –In accordance with national culture(s) and requirements
  20. 20. Principle 10: Records • Clinical trial information should be –Recorded, –Handled, and –Stored
  21. 21. • In a way that allows its accurate • Reporting, • Interpretation, and • Verification
  22. 22. Principle 11: Confidentiality / Privacy • Confidentiality of records should be protected
  23. 23. Principle 12: Good Manufacturing Practice(s) • Investigational products should be –Manufactured, –Handled, and –Stored in accordance with applicable GMP
  24. 24. Principle 13: Quality Systems • Systems with procedures that assure the quality of every aspect of the trial should be implemented
  25. 25. Investigator • Investigator’s Qualifications and Agreement • Adequate Resources • Medical Care of Trial Subjects • Communication with IRB/IEC • Compliance with Protocol • Investigational Product(s) • Informed Consent of Trial Subjects • Records and Reports • Final Report(s) by Investigator
  26. 26. Sponsor • Quality Assurance and Quality Control • Contract Research Organization (CRO) • Medical Expertise • Trial Design • Trial Management, Data Handling, and Record Keeping • Investigator Selection • Allocation of Responsibilities
  27. 27. SPONSOR(Cont.) • Compensation to Subjects and Investigators • Financing • Confirmation of Review by IRB/IEC • Information on Investigational Product(s) • Manufacturing, Packaging, Labelling, and Coding Investigational Product(s) • Supplying and Handling Investigational Product(s) • Record Access
  28. 28. SPONSOR(Cont.) • Safety Information • Adverse Drug Reaction Reporting • Monitoring • Audit. • Noncompliance • Premature Termination or Suspension of a Trial
  29. 29. INVESTIGATOR’S BROCHURE(IB) • delineates the minimum information that should be included in an IB and provides suggestions for its layout – Summary ,Introduction , Physical, Chemical, and Pharmaceutical Properties and Formulation, Nonclinical Studies - Nonclinical Pharmacology , Pharmacokinetics and Product Metabolism in Animals , Toxicology , Effects in Humans ,Pharmacokinetics and Product Metabolism in Humans , Safety and Efficacy Marketing Experience Summary of Data and Guidance for the Investigator
  30. 30. THANK YOU

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