About the Book:

"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. 

Contents:

1.1. Documentation in Pharmaceutical Industry

1.2. Drug Master File (DMF)

1.3. Distribution of Records

1.4. Generic Drugs Product Development

1.5. Hatch-Waxman Act

1.6. Code of Federal Regulations (CFR)[1-4]

1.7. Drug Product Performance, IN VITRO

1.8. ANDA Regulatory Approval Process

1.9. Regulatory Requirements for Product Approval

1.10. SUPAC

1.11. Outsourcing BA & BE to CRO

1.12. Regulatory Requirements for Registration of API in US and EU

1.13. Biologics

1.14. U.S Registration for Foreign Drugs

1.15. Bioequivalence and Drug Product Assessment

1.16. Post Marketing Surveillance

2.1. Chemistry, Manufacturing and Controls (CMC)

2.2. CTD and E CTD

2.3. ICH Guidelines

2.4. Regulatory Requirement of EU, MHRA and TGA

3.1. Investigational Medicinal Product Dossier (IMOD)

3.2. Investigator’s Brochure

4.1. Development of Clinical Trial Protocol

4.2. Institutional Review Board (IRB)

4.3. Regulatory Requirements in Clinical Trails

4.4. Safety Monitoring and Reporting on Clinical Trails

4.5. Health Insurance and Portability and Liability Act

4.6. Informed Consent Process and Procedures

4.7. 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.