PHARMACEUTICAL REGULATORY AFFAIRS for First Year M Pharm Semester 1 As Per PCI Regulations | Dr. Kishor S. Jain | Nirali Prakashan

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Description

1. Documentation in Pharmaceutical Industry?Part I – 2. Documentation in Pharmaceutical Industry-Part II – 3. Regulatory Requirements for Product Approval – 4. CMC and Regulatory Framework for Medical Products – 5. ICH Guidelines and Regulatory Requirements of EU, MHRA, TGA and ROW Countries – 6. Non-Clinical Drug Development – 7. Investigation of Medicinal Products Dossier (IMPD) and Investigator Brochure (IB) – 8. Clinical Trials – 9. HIPAA, Requirement to Clinical Study Process, Pharmacovigilance Safety Monitoring In Clinical Trials

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      PHARMACEUTICAL REGULATORY AFFAIRS for First Year M Pharm Semester 1 As Per PCI Regulations | Dr. Kishor S. Jain | Nirali Prakashan