Fundamentals of Pharmaceutical and Biologics Regulations (subscription)

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Section I: General Information

Chapter 1: Healthcare Landscape and Drug Development
Chapter 2: The Drug Development Continuum, Preclinical to Market Access
Chapter 3: International Harmonization via ICH, WHO, and other Global Initiatives

Section II: Nonclinical Studies

Chapter 4: Principles of Good Laboratory Practice and Nonclinical Development
Chapter 5: Safety Pharmacology Studies
Chapter 6: Pharmacokinetic and Toxicokinetic Studies
Chapter 7: Genotoxicity Studies
Chapter 8: Carcinogenicity Studies
Chapter 9: Developmental and Reproductive Toxicity Assessments
Chapter 10: Regulatory Environmental Risk Assessment of Human Pharmaceuticals

Section III: Chemistry, Manufacturing, Controls

Chapter 11: The Global Regulatory Process for the Registration of Active Substances
Chapter 12: Coordinating Drug Supply for Clinical and Non-Clinical Development
Chapter 13: Pharmaceutical Development Studies and Manufacturing Experience
Chapter 14: Analytical Development – Testing & Stability

Section IV: Clinical Trials

Chapter 15: Application Submission Types and Required Data (and History)
Chapter 16: Phases of Development (1,2,3,4)
Chapter 17: Enhancing Diversity in Clinical Trials
Chapter 18: Health Authority Interactions
Chapter 19: Pediatrics
Chapter 20: Regional-Specific Studies

Section V: Marketing Authorization

Chapter 21: Framework for Benefit-Risk Assessment
Chapter 22: eCTD and Digital Applications
Chapter 23: Expedited Approval Pathways
Chapter 24: Dossier Requirements

Section VI: Postmarketing Authorization

Chapter 25: Postauthorization Commitments
Chapter 26: Transfers and Renewals
Chapter 27: Product Extensions, Variations, and Supplements
Chapter 28: Compliance
Chapter 29: Recalls
Chapter 30: Postmarket Surveillance
Chapter 31: Advertising and Promotion
Chapter 32: Market Access—Reimbursement and Pricing

Linda McBride, RPh, RAC-US and Siegfried Schmitt, PhD, editors

Contributing Authors

About the Book

Available formats: print, e-book, and 3-year digital subscription

In a global regulatory environment, finding the information necessary to move a medicinal product to market can be daunting. There is no one-stop reference that covers the entire drug lifecycle – until now.

Fundamentals of Pharmaceutical and Biologics Regulations: A Global Perspective, is the reference you are searching for. Consolidating the knowledge of more than 50 subject matter experts across 32 chapters, this book places all the laws, regulations, and guidances needed at your fingertips – whether accessed via the hardcover book or searched for in the e-book.

In a world of global commerce, most regulatory professionals must interact with regulators in multiple jurisdictions. The relevant information is widely dispersed. With Fundamentals of Pharmaceutical and Biologics Regulations: A Global Perspective, you can find much of what you need, including additional background information, such as actual approval timelines versus timelines suggested by the regulators, in just one place.

This brand-new book includes sections covering general information; nonclinical safety; chemistry, manufacturing, and controls (CMC); clinical trials; and marketing authorization, as well as explanations of guidances from the usual suspects – the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the International Council on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Added to that, the authors have combed the globe to include critical information from a host of additional regulators such as ANVISA, Health Canada, NMPA, ANMAT, COFEPRIS, TGA, MedSafe, PMDA, and more.

Who will benefit from this book?

Fundamentals of Pharmaceutical and Biologics Regulations: A Global Perspective was developed for regulatory professionals of all levels of RAPS Regulatory Competency Framework including newcomers and seasoned professionals as well as academics and governmental employees. Regulatory professionals at Levels 1 and 2 of the framework will be able to easily access relevant drugs and biologics regulations and guidance in specific countries and how to apply them in one convenient place. For more senior professionals at Levels 3 and 4 responsible for global regulatory strategy, the book will serve as a valuable resource to facilitate strategic discussions on drugs and biologics regulations and policy worldwide.

Regulatory information is all over the place – there is an article here, a book chapter there. Some are in Chinese, some are in English, and others in yet another language. There was no comprehensive source for a global regulatory perspective on drugs and biologics. This is why this book is an absolute necessity.

Siegfried Schmitt, PhD

RAPS Editorial Advisory Committee

Purchasing Options

This book can be purchased in the following formats:

Pharmaceuticals and Biologics Fundamentals subscription.* A three-year subscription including the digital e-book version as well as automatic updates whenever a new edition and/or chapters are released during the subscription period.
Digital e-book. Single purchase; accessible online via RAPS Library online reader and downloadable.
Printed book.

This book can also be purchased as part of the following bundles:

All Access Library (12-month digital subscription)
Regulatory Excellence Bundle: Fundamentals (subscription).* Includes the digital e-book subscription to:
- Fundamentals of Medical Device Regulations: A Global Perspective
- Fundamentals of Pharmaceutical and Biologics Regulations: A Global Perspective
Regulatory Excellence Bundle: Pharmaceutical and Biologics (subscription).* Includes the digital e-book subscription to:
- Fundamentals of Pharmaceutical and Biologics Regulations: A Global Perspective
- Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition
- Regulatory Intelligence Reimagined
RAC exam test prep bundles

*All subscriptions listed above (excluding the All Access Library) are for three years. They grant you access to the products in the bundle. During this period, you can read the content online or download books as PDFs for offline use. You’ll also receive automatic updates to any new editions of the books and/or chapters included in your subscription. Learn more about subscriptions.

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