JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD

DRUG REGULATION AND REGISTRATION LAB

M.Pharmacy I Year I Semester (R19)

List of Experiments:

  • 1. Case studies on Change Management/ Change control. Deviations and Corrective & Preventive Actions (CAPA)
  • 2. Import of drugs for research and developmental activities
  • 3. GMP Audit Requirements as per CDSCO
  • 4. Preparation of checklist for registration of IND as per ICH CTD format.
  • 5. Preparation of checklist for registration of NDA as per ICH CTD format.
  • 6. Preparation of checklist for registration of ANDA as per ICH CTD format.
  • 7. Comparative study of DMF system in US, EU and Japan
  • 8. Preparation of regulatory submission using eCTD software
  • 9. Documentation of raw materials analysis as per official monographs
  • 10. Preparation of audit checklist for various agencies
  • 11. Preparation of submission to FDA using eCTD software
  • 12. Preparation of submission to EMA using eCTD software
  • 13. Preparation of submission to MHRA using eCTD software R19 M.PHARM PHARMACEUTICAL REGULATORY AFFAIRS M.Pharm (Pharmaceutical Regulatory Affairs)

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