Good Clinical Practice (GCP) & Regulatory Affairs

Kindly write to mcuriefoundation@gmail.com for online training on Good Clinical Practice (GCP), Regulatory Affairs or/and infection control programs

• CDSCO/DCGI, India
  • Clinical Trials in India:
    • https://cdsco.gov.in/opencms/opencms/en/Clinical-Trial/clinical-trials/
    • New Clinical Trial Rules 2019
      • https://cdsco.gov.in/opencms/opencms/en/Acts-and-rules/New-Drugs/
  • New Drugs:
    • https://cdsco.gov.in/opencms/opencms/en/Drugs/New-Drugs/
  • Medical Device Rules, 2017:
    • GSR 78(E), dt. 31-1-2017, w.e.f. 1-1-2018, As amended vide GSR 777(E) dt. 14-10-2022(w.e.f. 14-10-2022
      • https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTg4NQ==
      • https://cdsco.gov.in/opencms/opencms/en/Acts-and-rules/Medical-Devices-Rules/
  • Biologicals:
    • https://cdsco.gov.in/opencms/opencms/en/biologicals/
  • Bioavailability & Bioequivalence Studies
    • https://cdsco.gov.in/opencms/opencms/en/bioequi_bioavail/
• GCP Training by Dr. Rajendra Jani
  • https://drive.google.com/file/d/1fzH2r9e9eJYuV52U7eSeN8H3sXRiVqGn/view?usp=drive_link
• US FDA:
  • Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards MARCH 2024.
    • This guidance provides recommendations on provisions of the Department of Health and Human 20 Services (HHS) regulations on the protection of human subjects as well as certain proposed revisions to FDA’s current regulations for the protection of human subjects.
      • https://www.fda.gov/media/176663/download