Current Regulatory Requirements for Conducting Clinical Trials in India for Investigational New Drugs - New Drug

Current Regulatory Requirements for Conducting Clinical Trials in India for Investigational New Drugs - New Drug

NPTEL-NOC IITM via YouTube Direct link

Requirements for import/ manufacture of new drug/ IND for conducting clinical trials in India

15 of 29

15 of 29

Requirements for import/ manufacture of new drug/ IND for conducting clinical trials in India

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Current Regulatory Requirements for Conducting Clinical Trials in India for Investigational New Drugs - New Drug

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  1. 1 Introductory Video 1
  2. 2 Courses Overview
  3. 3 Overview of Indian regulatory system
  4. 4 Overview of Drugs & Cosmetics Act and Rules thereunder
  5. 5 Overview of New Drugs and Clinical Trials Rules, 2019
  6. 6 PRE-CLINICAL DATA REQUIREMENTS
  7. 7 RULES GOVERNING CLINICAL TRIALS
  8. 8 Phases of Clinical Trial, Forms, and Fees
  9. 9 Regulatory pathway and data requirements for NDCT, 2019
  10. 10 BA/BE study and study Centers: Legal provisions
  11. 11 Guidelines to conduct BA/BE studies
  12. 12 Ethics Committee registration and Re-registration
  13. 13 Ethical Considerations
  14. 14 Good Clinical Practice
  15. 15 Requirements for import/ manufacture of new drug/ IND for conducting clinical trials in India
  16. 16 Requirements for Import/ manufacture of new drug/ IND for sale/ distribution...
  17. 17 Important Issues
  18. 18 Special Concern
  19. 19 Clinical Trial Related Guidelines (NDCT Rules)
  20. 20 Content of Proposed Clinical Trial Protocol
  21. 21 Content of a Clinical Trial Report
  22. 22 Post Marketing Assessment & Clinical Trial Compensation
  23. 23 Common observations during submission of CT/BA/BE protocol
  24. 24 Common observations during CT/BA/BE centre inspections
  25. 25 Drug development process: Overview
  26. 26 Salient feature of NDCT 2019 - what's new in NDCT?
  27. 27 Online Submission 23A: SUGAM
  28. 28 ONLINE SUBMISSION (CTRI)
  29. 29 TABLES GIVEN IN NDCT 2019 AND ITS CONTENT

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