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

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Authors Name	Dr. Kishor S. Jain, Ms. Shakila S. Shaikh, Ms. Nilakshi V. Nerkar
ISBN 13	9789369939947
Publisher	Nirali Prakashan
Edition	First
Pages	324
Language	English
Publishing Year	Aug-25

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SKU: N3787 Categories: Books for M.Pharmacy As Per P.C.I Regulations Syllabus, First Year MPharm - Semester 1, Pharmacy Textbooks

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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

Additional information

Weight	450 g
Dimensions	24 × 18 × 2 cm
Language	English
Publisher	Nirali Prakashan – Publication
Semester - Year	First Year M. Pharm. Semester 1
University	As Per PCI Syllabus