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Regulatory Affairs: Basic Protocols
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"Regulatory Affairs: Basic Protocols" provides a comprehensive guide to the basic concepts and protocols in the pharmaceutical industry. Written in a clear and concise manner, this book covers topics including documentation, chemistry, manufacturing, and controls, as well as the investigation of medicinal product dossier and the development of clinical trial protocols. Throughout the book, readers will learn about the concept of innovator and generic drugs, drug development, and the regulatory guidance and guidelines for filing and approval.
This book also explores the preparation of dossiers and their submission to regulatory agencies in different countries, as well as post-approval regulatory requirements for actives and drug products. Readers will also gain valuable insights into the submission of global documents in CTD/eCTD formats, clinical trial requirements for approvals for conducting clinical trials, pharmacovigilance, and the process of monitoring clinical trials.
"Regulatory Affairs: Basic Protocols" is an indispensable resource for anyone looking to gain a deeper understanding of the regulatory affairs landscape in the pharmaceutical industry. With clear descriptions, helpful figures, and illustrative examples, this book will make the subject more accessible and interesting for any reader.
Contents:1.1. Documentation in Pharmaceutical Industry1.2. Drug Master File (DMF)1.3. Distribution of Records1.4. Generic Drugs Product Development1.5. Hatch-Waxman Act1.6. Code of Federal Regulations (CFR)[1-4]1.7. Drug Product Performance, IN VITRO1.8. ANDA Regulatory Approval Process1.9. Regulatory Requirements for Product Approval1.10. SUPAC1.11. Outsourcing BA & BE to CRO1.12. Regulatory Requirements for Registration of API in US and EU1.13. Biologics1.14. U.S Registration for Foreign Drugs1.15. Bioequivalence and Drug Product Assessment1.16. Post Marketing Surveillance2.1. Chemistry, Manufacturing and Controls (CMC)2.2. CTD and E CTD2.3. ICH Guidelines2.4. Regulatory Requirement of EU, MHRA and TGA3.1. Investigational Medicinal Product Dossier (IMOD)3.2. Investigator’s Brochure4.1. Development of Clinical Trial Protocol4.2. Institutional Review Board (IRB)4.3. Regulatory Requirements in Clinical Trails4.4. Safety Monitoring and Reporting on Clinical Trails4.5. Health Insurance and Portability and Liability Act4.6. Informed Consent Process and Procedures4.7. Pharmacovigilance
About the Authors:Sankar Veintramuthu, Vice Principal, Professor and Head, Dept. of Pharmaceutics, P.S.G. College of Pharmacy, Coimbatore (Tamil Nadu), is an expert in Biopharmaceutics and Pharmacokinetics. He has been awarded many best research paper awards. He is the recipient of Best Pharmacy Teacher from The Tamil Nadu Dr. MGR medical university, Chennai, and PSG Son’s and Charites, Coimbatore. He has participated in 4 International and 12 National conferences. With funding support from the Tamil Nadu State Council for Science and Technology, Chennai, Indian Council of Medical Research (ICMR), New Delhi, All India Council for Technical Education, New Delhi, and Department of Science and Technology, New Delhi, he has organized 5 conferences/ seminars. He is the Editor of the International Journal of Pharma Research and a Research Reviewer for two international journals namely Informa World Journal (UK) and Biosciences Asia (Thailand). He has received two funded projects from CSIR and The Tamil Nadu Dr. MGR Medical University. He has guided 35 M pharm and 5 Ph.D. He is an active member of pharmacy bodies such as IPA, APTI, IPGA, and IHPA. To his credit, he has one patent and one textbook on Novel Drug Delivery Systems, and 91 research papers. He has also published two book chapters.
S. Pranav Ragavendra, Research scholar, Department of Pharmaceutics, P.S.G College of Pharmacy, Coimbatore (Tamil Nadu). He has been awarded as the best student by the Indian Society of Technical Education, in the year 2018. His M Pharm Research Project has been awarded as the best Poster at the International Conference conducted by the Association of Pharmaceutical Research (APR) held in Dubai, UAE. He has participated in 4 international conferences and 10 National conferences. He is the founder of UDO INDIA which is an organization that educates people in the field of Medicine and hygiene practices. Currently, he is doing full-time research in the field of Nanoparticles with chemotherapeutic drugs at PSG College of Pharmacy, Coimbatore, Tamil Nadu, India.
This book also explores the preparation of dossiers and their submission to regulatory agencies in different countries, as well as post-approval regulatory requirements for actives and drug products. Readers will also gain valuable insights into the submission of global documents in CTD/eCTD formats, clinical trial requirements for approvals for conducting clinical trials, pharmacovigilance, and the process of monitoring clinical trials.
"Regulatory Affairs: Basic Protocols" is an indispensable resource for anyone looking to gain a deeper understanding of the regulatory affairs landscape in the pharmaceutical industry. With clear descriptions, helpful figures, and illustrative examples, this book will make the subject more accessible and interesting for any reader.
Contents:1.1. Documentation in Pharmaceutical Industry1.2. Drug Master File (DMF)1.3. Distribution of Records1.4. Generic Drugs Product Development1.5. Hatch-Waxman Act1.6. Code of Federal Regulations (CFR)[1-4]1.7. Drug Product Performance, IN VITRO1.8. ANDA Regulatory Approval Process1.9. Regulatory Requirements for Product Approval1.10. SUPAC1.11. Outsourcing BA & BE to CRO1.12. Regulatory Requirements for Registration of API in US and EU1.13. Biologics1.14. U.S Registration for Foreign Drugs1.15. Bioequivalence and Drug Product Assessment1.16. Post Marketing Surveillance2.1. Chemistry, Manufacturing and Controls (CMC)2.2. CTD and E CTD2.3. ICH Guidelines2.4. Regulatory Requirement of EU, MHRA and TGA3.1. Investigational Medicinal Product Dossier (IMOD)3.2. Investigator’s Brochure4.1. Development of Clinical Trial Protocol4.2. Institutional Review Board (IRB)4.3. Regulatory Requirements in Clinical Trails4.4. Safety Monitoring and Reporting on Clinical Trails4.5. Health Insurance and Portability and Liability Act4.6. Informed Consent Process and Procedures4.7. Pharmacovigilance
About the Authors:Sankar Veintramuthu, Vice Principal, Professor and Head, Dept. of Pharmaceutics, P.S.G. College of Pharmacy, Coimbatore (Tamil Nadu), is an expert in Biopharmaceutics and Pharmacokinetics. He has been awarded many best research paper awards. He is the recipient of Best Pharmacy Teacher from The Tamil Nadu Dr. MGR medical university, Chennai, and PSG Son’s and Charites, Coimbatore. He has participated in 4 International and 12 National conferences. With funding support from the Tamil Nadu State Council for Science and Technology, Chennai, Indian Council of Medical Research (ICMR), New Delhi, All India Council for Technical Education, New Delhi, and Department of Science and Technology, New Delhi, he has organized 5 conferences/ seminars. He is the Editor of the International Journal of Pharma Research and a Research Reviewer for two international journals namely Informa World Journal (UK) and Biosciences Asia (Thailand). He has received two funded projects from CSIR and The Tamil Nadu Dr. MGR Medical University. He has guided 35 M pharm and 5 Ph.D. He is an active member of pharmacy bodies such as IPA, APTI, IPGA, and IHPA. To his credit, he has one patent and one textbook on Novel Drug Delivery Systems, and 91 research papers. He has also published two book chapters.
S. Pranav Ragavendra, Research scholar, Department of Pharmaceutics, P.S.G College of Pharmacy, Coimbatore (Tamil Nadu). He has been awarded as the best student by the Indian Society of Technical Education, in the year 2018. His M Pharm Research Project has been awarded as the best Poster at the International Conference conducted by the Association of Pharmaceutical Research (APR) held in Dubai, UAE. He has participated in 4 international conferences and 10 National conferences. He is the founder of UDO INDIA which is an organization that educates people in the field of Medicine and hygiene practices. Currently, he is doing full-time research in the field of Nanoparticles with chemotherapeutic drugs at PSG College of Pharmacy, Coimbatore, Tamil Nadu, India.
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