JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD

REGULATORY ASPECTS OF HERBALS AND BIOLOGICAL LAB

M.Pharmacy I Year II Semester (R22)

List of Experiments:

  • 1. Preparation of Biologics License Applications (BLA)
  • 2. Preparation of documents required for Vaccine Product Approval
  • 3. Comparison of clinical trial application requirements of US, EU and India of Biologics
  • 4. Preparation of Checklist for Registration of Blood and Blood Products
  • 5. Registration requirement comparison study in 5 emerging markets (WHO) and preparing check list for market authorization
  • 6. Registration requirement comparison study in emerging markets (BRICS) and preparing check list for market authorization
  • 7. Registration requirement comparison study in emerging markets (China and South Korea) and preparing check list for market authorization
  • 8. Registration requirement comparison study in emerging markets (ASEAN) and preparing check list for market authorization
  • 9. Registration requirement comparison study in emerging markets (GCC) and preparing check list for market authorization
  • 10. Preparation of document required for the approval of herbal products of diverse dosage forms(3products) as per regulations requirements Practical work shall be carried out based on the theory syllabus. M.Pharm I Year II Sem (Pharmaceutical Regulatory Affairs)

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