Call for the book chapters: Pharmaceutical regulatory affairs-I

ShivKesh Publication is pleased to invite book chapter contributions for an upcoming edited volume titled “Pharmaceutical Regulatory Affairs-I”, edited by Dr. Chinmaya Mahapatra, Associate Professor & HOD, Department of Regulatory Affairs, School of Pharmacy, Parul University, Vadodara. This book aims to provide a comprehensive understanding of regulatory frameworks, documentation practices, and clinical research guidelines, making it an essential reference for students, researchers, academicians, and industry professionals in the pharmaceutical sciences.

Scope of the Book

The book Pharmaceutical Regulatory Affairs-I provides a comprehensive overview of the principles and practices governing the regulation of pharmaceuticals, cosmetics, biologicals, herbals, nutraceuticals, and medical devices. It covers good regulatory practices (GMP, GLP, GDP, GxP), documentation and dossier preparation, clinical trial regulations, audits, inspections, and global perspectives with emphasis on Indian, US, and EU guidelines. Special focus is given to bioavailability/bioequivalence studies, pharmacopoeial standards, BIS/ISO compliance, and intellectual property rights. Serving as a bridge between academia and industry, this book is designed for students, researchers, professionals, and policy makers to understand regulatory frameworks and their real-world applications, while keeping pace with evolving global trends and challenges in pharmaceutical regulation.

Recommended Topics

The book is structured into four major units, covering 20 chapters:

Unit I: Good Regulatory Practices

• Chapter 1: Current Good Manufacturing Practices

Introduction, US cGMP Part 210 and Part 211.EC Principles of GMP (Directive 91/356/EEC) Article 6 to Article 14 and WHO cGMP guidelines, GAMP-5; Medical device and IVDs Global Harmonisation Task Force(GHTF) Guidance docs.

• Chapter 2:Good Laboratory Practices

Introduction, USFDA GLP Regulations (Subpart A to Subpart K), Controlling the GLP inspection process, Documentation, Audit, goals of Laboratory, Quality Audit, Audit tools, Future of GLP regulations, relevant ISO and Quality Council of India(QCI) Standards.

• Chapter 3:Good Automated Laboratory Practices

Introduction to GALP, Principles of GALP, GALP Requirements, SOPs of GALP, Training Documentation,21 CFR Part 11, General checklist of 21CFR Part 11, Software Evaluation checklist, relevant ISO and QCI Standards.

• Chapter 4:Good Distribution Practices

Introduction to GDP, Legal GDP requirements put worldwide, Principles, Personnel, Documentation, Premises and Equipment, Deliveries to Customers, Returns, Self-Inspection, Provision of information, Stability testing principles, WHO GDP, USP GDP (Supply chain integrity), relevant CDSCO guidance and ISO standards.

• Chapter 5:Quality Management Systems

Concept of Quality, Total Quality Management, Quality by design, Six Sigma concept, Out of Specifications (OOS), Change control. Validation: Types of Validation, Types of Qualification, Validation master plan (VMP), Analytical Method Validation. Validation of utilities, [Compressed air, steam, water systems, Heat Ventilation and Air conditioning (HVAC)]and Cleaning Validation. The International Conference on Harmonization (ICH) process, ICH guidelines to establish quality, safety and efficacy of drug substances and products, ISO 13485, Sch MIII and other relevant CDSCO regulatory guidance documents.

Unit II: Documentation and Regulatory Writing

• Chapter 6: Documentation in the Pharmaceutical Industry

Exploratory Product Development Brief (EPDB) for Drug substance and Drug product, Product Development Plan (PDP), Product Development Report (PDR), Master Formula Record, Batch Manufacturing Record and its calculations, Batch Reconciliation, Batch Packaging Records, Print pack specifications, Distribution records, Certificate of Analysis (CoA), Site Master File and Drug Master Files (DMF).

• Chapter 7: Dossier Preparation and Submission

Introduction and overview of dossiers, contents and organization of dossier, binders and sections, compilation and review of dossier. Paper submissions, overview and modules of CTD, electronic CTD submissions; Electronic submission: Planning electronic submission, requirements for submission, regulatory bindings and requirements, Tool and Technologies, electronic dossier submission process and validating the submission, Electronic Submission Gateway (ESG). Non eCTD electronic submissions (NeeS), Asian CTD formats (ACTD) submission. Organizing, process and validation of submission. Submission in Sugam system of CDSCO

• Chapter 8: Audits

Introduction, Definition, Summary, Types of audits, GMP compliance audit, Audit policy, Internal and External Audits, Second Party Audits, External third party audits, Auditing strategies, Preparation and conducting audit, Auditing strategies, audit analysis, audit report, audit follow-up. Auditing/inspection of manufacturing facilities by regulatory agencies. Timelines for audits/inspection. GHTF study group 4 guidance document. ISO 13485.

• Chapter 9: Inspections

Pre-approval inspections, Inspection of pharmaceutical manufacturers, Inspection of drug distribution channels, Quality systems requirements for national good manufacturing practice inspectorates, inspection report, model certificate of good manufacturing practices, Root cause analysis, Corrective and Preventive action (CAPA).

• Chapter 10: Product Life Cycle Management

Prior Approval Supplement (PAS), Post Approval Changes [SUPAC], Changes Being Effected in 30 Days (CBE-30), Annual Report, Post marketing Reporting Requirements, Post approval Labeling Changes, Lifecycle Management, FDA Inspection and Enforcement, Establishment Inspection Report (EIR), Warning Letters, Recalls, Seizure and Injunctions. ISO Risk Management Standard.

Unit III: Clinical Research Regulations

• Chapter 11: Clinical Drug Development Process

Different types of Clinical Studies, Phases of clinical trials, Clinical Trial protocol, PSUR, Clinical Investigation and Evaluation of Medical Devices & IVDs, Different Types of Studies, Key Concepts of Medical Device Clinical Evaluation, Key Concepts of Clinical Investigation

• Chapter 12: Ethics in Clinical Research

Historical Perspectives: Nuremberg Code, Thalidomide study, Nazis Trials, Tuskegee Syphilis Study, The Belmont Report, the declaration of Helsinki, Origin of International Conference on Harmonization- Good Clinical Practice (ICH-GCP) guidelines, The ethics Randomised Clinical Trials, The Role of Placebos in Clinical Trials, Ethics of Clinical Research in Special Populations, Institutional Review Committee/Ethics Board/Independent Ethics Committee– composition, roles, responsibilities, review and approval process and ongoing monitoring of safety data, Data safety monitoring boards.Responsibilities of the sponsor, CRO, and investigator in ethical conduct of clinical research, Ethical principles governing the informed consent process, Patient Information Sheet and Informed Consent Form, The informed consent process and documentation

• Chapter 13: Regulations Governing Clinical Trials

India: Clinical Research regulations in India– Schedule Y & Medical Device Guidance.
USA: Regulations to conduct drug studies in USA (FDA), NDA505(b)(1) of the FD&C Act (Application for approval of a new drug), NDA505(b)(2) of the FD&C Act (Application for approval of a new drug that relies, at least in part, on data not developed by the applicant), ANDA505(j) of the FD&C Act (Application for approval of a generic drug product), FDA Guidance for Industry- Acceptance of Foreign Clinical Studies, FDA Clinical Trials Guidance Document: Good Clinical Practice.
EU: Clinical Research regulations in the European Union (EMA)

• Chapter 14: Clinical Research Guidelines

Good Clinical Practice Guidelines (ICH GCP E6), Indian GCP Guidelines, ICMREthical Guidelines for Biomedical Research, CDSCO guidelines, GHTF study group 5guidance documents, Regulatory Guidance on Efficacy and Safety, ICH Guidance’s, E4– Dose Response Information to support Drug Registration, E7–Studies in support of General Population: Geriatrics, E8–General Considerations of Clinical Trials, E10– Choice of Control Groups and Related Issues in Clinical Trials, E 11– Clinical Investigation of Medicinal Products in the Pediatric Population, General biostatistics principle applied in clinical research

• Chapter 15: USA & EU Guidance

USA: FDA Guidance, CFR 21Part50: Protection of Human Subjects, CFR 21 Part 54: Financial Disclosure by Clinical Investigators, CFR 21 Part312: IND Application, CFR 21 Part 314: Application for FDA Approval to Market a New Drug, CFR 21 Part 320: Bioavailability and bioequivalence requirements, CFR 21 Part 812: Investigational Device Exemptions, CFR 21 Part 822: Post-market surveillance, FDA Safety Reporting Requirements for INDs and BA/BE Studies, FDA MedWatch, Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment, European Union: EMA Guidance, EUDirectives 2001, EudraLex (EMEA) Volume 3– Scientific guidelines for medicinal products for human use, EU Annual Safety Report (ASR), Volume 9A– Pharmacovigilance for Medicinal Products for Human Use EUMDD with respect to clinical research, ISO14155

Unit IV: Regulations and Legislation

• Chapter 16: Rules for Biologicals, Herbals, and Nutraceuticals

Drugs and Cosmetics Act 1940 and Rules 1945: DPCO and NPPA, Other relevant provisions (rules, schedules, and guidelines for approval of Drugs & Cosmetics, Medical Devices, Biologicals & Herbals, and Food & Nutraceuticals in India. Other relevant Acts: Narcotic Drugs and Psychotropic Substances Act; Medicinal and Toilet Preparations (Excise Duties) Act, 1955; Pharmacy Act, 1948; Drugs and Magic Remedies (Objectionable Advertisements) Act, 1955; Prevention of Cruelty to Animals Act.

• Chapter 17: Regulatory Requirements for Drugs, Cosmetics, and Medical Devices Biologicals & Herbals, and Food & Nutraceuticals

CDSCO (Central Drug Standard Control Organization) andState Licensing Authority: Organization, Responsibilities such as  Rules, regulations, guidelines and standards for regulatory filing of Drugs & Cosmetics, Medical Devices, Biologicals & Herbals, and Food & Nutraceuticals Format and contents of Regulatory dossier filing Clinical trial/ investigations

• Chapter 18: Indian Pharmacopoeial Standards, BIS & ISO
• Chapter 19: Bioavailability & Bioequivalence Studies

Bioavailability and Bioequivalence data (BA &BE), BCS
Classification of Bioequivalence study Drugs, Regulatory Stability requirements: ICH and WHO, Requirements for Guidelines for Drug testing in animals/Preclinical Studies Animal testing: Rationale for conducting studies, CPCSEA Guidelines Ethical guidelines for human participants ICMR-DBT Guidelines for Stem Cell Research

• Chapter 20: Intellectual Property Rights

Patent, Trademark, Copyright, Industrial Designs and Geographical Indications, Indian Patent Scenario. IPR vs Regulatory Affairs

 Editor

Dr. Chinmaya Mahapatra, M. Pharma, Ph.D. A gold medal awardee in a Master’s degree completed his Ph.D. from Berhampur University with DST INSPIRE Fellowship. He had accomplished his post-graduation diploma in Clinical Research from Bangalore. He has 11+ years of experience in the field of Pharmaceuticals and Pharmacovigilance. He has worked as a Quality Assurance officer for Ciron Drugs and  IPCA Laboratories Ltd. Currently, he is working as LQPPV (PvOI) for Intuvigilance UK and Director, CMPV Consultancy LLP. Along with this, he is also associated with the School of Pharmacy, Parul University, as a full-time Associate Professor & HOD of the Department of Regulatory Affairs.  He has published 3 books, 1 book chapter, 10 research articles and 16 patents, which includes 1 US patent, 4 UK design patents, 2 German patents, 2 South African patents and 7 Indian patents to his credit. He is a certified member of the Association of Clinical Research Professionals (ACRP) USA. Since 2020, he has been leading the international peer-reviewed “Journal of Pharmacovigilance and Drug Research (JPADR)” as Editor-in-Chief and is also the Founder President of the Global Pharmacovigilance Society.

 Important Dates

• Abstract Submission:01.10.2025
• Review Notification: 15.10.2025
• Chapter Submission: 15.12.2025
• Acceptance Notification: 05.01.2026

 Publication Charges

• Rs. 500/- per chapter

 Submission Guidelines

Authors can submit their abstracts and chapters to:
shivkeshpublication@gmail.com | info@shivkesh.com

Follow the Author’s instructions section for the chapter formatting, or download the template guideline.