Current Regulatory requirements for conducting Cinical trials

Wishlist Share
Share Course
Page Link
Share On Social Media

About Course

Current Regulatory requirements for conducting clinical trials.

Before a drug may be licensed for import, manufacturing, or marketing in the country, it must first demonstrate that it is safe and effective for human use. The Drugs and Cosmetics Rules, Rules 122A, 122B, and 122D, as well as Schedule Y’s Appendix I, IA, and VI, explain the information/data required for approval of clinical trials and/or the import or production of new drugs for marketing in the country. Recently, there are several adjustments made relating to the new drug rules. & “ New Drugs and Clinical Trial Rules, 2018. The CDSCO has published a (draught) document. This course will provide participants with a comprehensive understanding of the current regulatory and ethical standards for conducting clinical trials.

Syllabus for Current Regulatory requirements for conducting clinical trials.
Week 1: Overview, Definitions, and Drug Regulatory Agencies
Week 2: Drugs and Cosmetics Act and Rules (Applicable Acts and Rules), Drugs and Cosmetics Rules (Applicable CDSCO Guidelines), Drug Development Overview

Schedule Y: Overview, Schedule Y: Appendices,

Week 3: Good Clinical Practice (Indian), Schedule Y: Overview, Schedule Y: Appendices

Week 4: Ethical issues, recent revisions, and special concerns (Approval procedure for Medical device, Biologicals, Phytopharmaceuticals, rDNA derived products)

Show More

Course Content

C1L11

  • C1L10B
    00:00
  • C1L10A
    00:00
  • C1L09
    00:00
  • C1L07
    00:00
  • C1L08
    00:00
  • C1L06
    00:00
  • C1L05
    00:00
  • C1L04
    00:00
  • C1L02
    00:00
  • C1L01
    00:00
  • C1L03
    00:00
  • C1L00
    00:00
  • C1 Introduction Assorted Interviews
    00:00

Student Ratings & Reviews

No Review Yet
No Review Yet
ResearcherStore

Want to receive push notifications for all major on-site activities?