Books Catalog

Featured Books:
E-booksE-books
Postmarket Requirements for Medical Devices: A Practical Guide (e-book)
Member: $175.00 Nonmember: $245.00
This book is a comprehensive guide covering product change evaluation, postmarket surveillance, and compliance with audit/inspection requirements in the medical device industry.
BooksBooks
Fundamentals of Medical Device Regulations, Fifth Edition
Member: $295.00 Nonmember: $395.00
A current view of regulations governing medical devices and IVDs, and covers the entire medical device lifecycle, from product development through postmarketing.
BooksBooks
Fundamentals of Pharmaceutical and Biologics Regulations, Fourth Edition
Member: $295.00 Nonmember: $395.00
Bundle comprises the pharmaceutical and biologics subsets from all four Fundamentals of Regulatory Affairs books (US, EU, Canada, and international).
BooksBooks
Software as a Medical Device
Member: $145.00 Nonmember: $200.00
SaMD will help readers uncover whether their software is subject to global medical device regulations, understand the regulatory implications, and develop their SaMD strategy.
E-booksE-books
Nutrition, Health, and Disease: Regulatory Policy Matters
Member: $145.00 Nonmember: $200.00
This book depicts the importance of nutrition and the gut microbiome in noncommunicable chronic diseases (NCD) prevention and management.
BooksBooks
European Medical Device Regulation Desktop Reference Booklet
Member: $70.00 Nonmember: $100.00
BooksBooks
Fundamentals of US Regulatory Affairs, 11th Edition (2022 Update)
Member: $205.00 Nonmember: $275.00
This 11th edition presents information covering all lifecycle stages of regulated healthcare products in the US.
E-booksE-books
Postapproval Changes for Drugs: A Practical Guide (e-book)
Member: $160.00 Nonmember: $225.00
This guide covers postapproval changes from marketing authorization transfers, administrative changes, late phase renewals through to additional indications.
BooksBooks
Regulation of Regenerative Medicines: A Global Perspective
Member: $145.00 Nonmember: $200.00
Regulation of Regenerative Medicines: A Global Perspective takes a look inside the rapidly evolving cell therapy, gene therapy, and tissue engineering landscape in the US and other key world markets.
E-booksE-books
Quality Management Systems for Drugs and Devices (e-book)
Member: $205.00 Nonmember: $285.00
Quality Management Systems for Drugs and Devices presents a comprehensive overview of quality management systems, including quality assurance, GMP, GLP, GCP, and compliance.
BooksBooks
Global Pediatric Development of Drugs, Biologics, and Medical Devices
Member: $130.00 Nonmember: $180.00
This book takes a comprehensive look at global regulations, guidance, and incentives for the development of products for the pediatric population.
E-booksE-books
Orphan Drug Development for Rare Diseases (e-book)
Member: $130.00 Nonmember: $180.00
Orphan Drug Development for Rare Diseases covers every aspect of orphan drug development. Topics include incentives, benefits, patient engagement, designation, marketing authorization, and market access.
BooksBooks
Lifecycle Management Through the Rx-to-OTC Switch
Member: $145.00 Nonmember: $200.00
Lifecycle Management Through the Rx-to-OTC Switch is a must read for anyone involved in or responsible for understanding the regulatory requirements and developmental stages of a successful switch program.
BooksBooks
Fundamentals of International Regulatory Affairs, Fifth Edition
Members: $295 Nonmembers: $395
This edition discusses regulatory changes that have occurred globally and technologically with a focus on drugs and medical devices.
BooksBooks
The European Medical Device Regulation (2021 Update)
Member: $295.00 Nonmember: $395.00
Your “go-to” EU MDR guide and tool kit intended to be your companion to reference time and time again.
BooksBooks
International Combination Products
Member: $130.00 Nonmember: $180.00
This book provides an in-depth look at this breakthrough field and covers three major regulatory regions – the US, Canada, and Europe.
E-booksE-books
Regulatory Intelligence 101, Third Edition (e-book)
Member: $130.00 Nonmember: $180.00
Comprised of 25 chapters from 30 experts from seven different countries, this new edition incorporates a global overview of regulatory intelligence.
BooksBooks
Regulatory Writing: An Overview, Second Edition
Member: $160.00 Nonmember: $225.00
This new edition is a valuable resource for professionals engaged in designing, composing, compiling, or commenting on regulatory documentation.
BooksBooks
Global Medical Device Regulatory Strategy, Second Edition
Member: $205.00 Nonmember: $285.00
Learn to develop a comprehensive global regulatory strategy for medical devices, labeling, clinical, risk management, marketing, and postmarketing.
BooksBooks
The European In Vitro Diagnostic Regulation
Member: $295.00 Nonmember: $395.00
RAPS has teamed up with Meddev Solutions to offer a practical guide to implementing the EU IVDR.
BooksBooks
Introduction to the Due Diligence Process, Second Edition
Member: $75.00 Nonmember: $125.00
Explore modern elements of the due diligence process, including the changing focus of document review, and the role of regulatory counsel.
BooksBooks
Fundamentals of EU Regulatory Affairs, Ninth Edition
Members: $295 Nonmembers: $395
Learn about the transformation of the EU healthcare product regulatory landscape, including the impact of Brexit and EMA’s move from London to Amsterdam.
BooksBooks
Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition
Member: $160.00 Nonmember: $225.00
This book presents a systematic approach to creating a global strategy to meet the requirements of multiple regulatory systems.
BooksBooks
Essentials of Healthcare Product Labeling
Member: $130.00 Nonmember: $180.00
Learn details on labeling for the full lifecycle of human healthcare products, from target labeling through submission and marketing in the US, EU and Canada.
BooksBooks
Fundamentals of Canadian Pharmaceutical, Biologic and Medical Devices Regulations
Member: $100.00 Nonmember: $150.00
A compilation of Fundamentals of Canadian Pharmaceutical and Biologics Regulations and Fundamentals of Canadian Medical Device Regulations.
BooksBooks
Promotion of FDA-Regulated Medical Products
Member: $130.00 Nonmember: $180.00
This book expands on RAPS’ 2013 publication, FDA Requirements for Prescription Drug Promotion by John Driscoll, to include prescription devices.
BooksBooks
Risk Evaluation and Mitigation Strategies for US Drug Development, Second Edition by Edward Tabor, MD
Member: $37.50 Nonmember: $62.50
A comprehensive analysis FDA’s REMS program, including insight from new guidance documents and recent REMS approvals.
BooksBooks
The Medical Device Validation Handbook, Second Edition
Member: $205.00 Nonmember: $285.00
The handbook covers device validation and revalidation throughout the product lifecycle, from design through postmarket.
BooksBooks
Risk Management Principles for Devices and Pharmaceuticals
Member: $130.00 Nonmember: $180.00
Expanded and updated risk management information on healthcare products around the world.
BooksBooks
EU Regulatory Acronyms & Definitions, Sixth Edition
Member : $10.00 Nonmember: $15.00
An EU reference guide with entries in biologics, medicinal products, and medical devices.
BooksBooks
International Regulatory Acronyms & Definitions, Third Edition
Member: $10.00 Nonmember: $15.00
International regulatory terms, definitions, and acronyms that will help you develop a better understanding of international regulations.
BooksBooks
Canadian Regulatory Acronyms & Definitions, Fifth Edition
Member: $10.00 Nonmember: $15.00
For those working in the Canadian market, entries of significance to the Canadian healthcare product industry.
BooksBooks
Eclectic Science and Regulatory Compliance: Stories for the Curious
Member: $15.00 Nonmember: $20.00
This is an informative, enjoyable read for individuals involved in the fields of medicine and science and those with curious minds.
BooksBooks
Fundamentals of Japanese Regulatory Affairs, Second Edition (Japanese language)
Member: $55.00 Nonmember: $75.00
This Japanese language version covers premarket and postmarket requirements for healthcare products.
BooksBooks
Complete GHTF Guidance Document Bundle
Member: $62.50 Nonmember: $82.50
A GHTF bundle of 24 guidances for medical devices: 10 from Study Group 1, eight from Study Group 2, three from Study group 3, two from Study Group 4 and one from Study Group 5.
BooksBooks
Complete WHO Guidance Document Bundle
Member: $15.00 Nonmember: $22.50
A WHO bundle with six guidance documents addressing pharmaceuticals, medical devices, psychotropic substances and plasma.
BooksBooks
Key Regulatory Topics: eCTD
Member: $87.50 Nonmember: $112.50
eCTD guidance documents from the ICH, EMA, and FDA.
BooksBooks
Terms & Definitions of Japanese Regulatory Affairs
Member: $32.50 Nonmember: $42.50
English translations of the most important Japanese regulatory terms and acronyms.
BooksBooks
Communication and Negotiation
Member: $15.00 Nonmember: $20.00
This book provides basic and detailed descriptions of the communication and negotiation skills necessary to achieve regulatory excellence.
BooksBooks
Choosing the Right Regulatory Career
Member: $20.00 Nonmember: $25.00
Research the diverse and demanding career options available to regulatory professionals across the industry. From traditional and alternative career pathways, explore the many ways to break into regulatory.
Fundamentals discount

RAPS Fundamentals of Regulatory Affairs Series provides the foundational knowledge needed to keep abreast of global regulations for pharmaceuticals, medical devices, biologics, and other healthcare products. This series constitutes the most extensive collection of resources available on global regulatory affairs and is essential for anyone who needs to know and understand regulations and legislation from various regions of the world, including the US, Europe, Canada, and Japan.

Learn More »
BooksBooks
Fundamentals of US Regulatory Affairs, 11th Edition (2022 Update)
Member: $205.00 Nonmember: $275.00
This 11th edition presents information covering all lifecycle stages of regulated healthcare products in the US.
BooksBooks
Fundamentals of Medical Device Regulations, Fifth Edition
Member: $295.00 Nonmember: $395.00
A current view of regulations governing medical devices and IVDs, and covers the entire medical device lifecycle, from product development through postmarketing.
BooksBooks
Fundamentals of Pharmaceutical and Biologics Regulations, Fourth Edition
Member: $295.00 Nonmember: $395.00
Bundle comprises the pharmaceutical and biologics subsets from all four Fundamentals of Regulatory Affairs books (US, EU, Canada, and international).
BooksBooks
Fundamentals of International Regulatory Affairs, Fifth Edition
Members: $295 Nonmembers: $395
This edition discusses regulatory changes that have occurred globally and technologically with a focus on drugs and medical devices.
BooksBooks
Fundamentals of EU Regulatory Affairs, Ninth Edition
Members: $295 Nonmembers: $395
Learn about the transformation of the EU healthcare product regulatory landscape, including the impact of Brexit and EMA’s move from London to Amsterdam.
BooksBooks
Fundamentals of Canadian Pharmaceutical, Biologic and Medical Devices Regulations
Member: $100.00 Nonmember: $150.00
A compilation of Fundamentals of Canadian Pharmaceutical and Biologics Regulations and Fundamentals of Canadian Medical Device Regulations.
BooksBooks
Fundamentals of Japanese Regulatory Affairs, Second Edition (Japanese language)
Member: $55.00 Nonmember: $75.00
This Japanese language version covers premarket and postmarket requirements for healthcare products.

RAPS medical devices collection will benefit individuals working in multinational medical device and in vitro diagnostic (IVD) product development and marketing at all levels—from seasoned regulatory personnel who need to check facts or are dealing with a new product type to those new to the profession. Gain access to global regulations for devices and in vitro diagnostic devices, from premarket through postmarket and represent the state of the art in regulatory sciences.

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E-booksE-books
Postmarket Requirements for Medical Devices: A Practical Guide (e-book)
Member: $175.00 Nonmember: $245.00
This book is a comprehensive guide covering product change evaluation, postmarket surveillance, and compliance with audit/inspection requirements in the medical device industry.
BooksBooks
European Medical Device Regulation Desktop Reference Booklet
Member: $70.00 Nonmember: $100.00
E-booksE-books
Quality Management Systems for Drugs and Devices (e-book)
Member: $205.00 Nonmember: $285.00
Quality Management Systems for Drugs and Devices presents a comprehensive overview of quality management systems, including quality assurance, GMP, GLP, GCP, and compliance.
BooksBooks
Global Pediatric Development of Drugs, Biologics, and Medical Devices
Member: $130.00 Nonmember: $180.00
This book takes a comprehensive look at global regulations, guidance, and incentives for the development of products for the pediatric population.
BooksBooks
The European Medical Device Regulation (2021 Update)
Member: $295.00 Nonmember: $395.00
Your “go-to” EU MDR guide and tool kit intended to be your companion to reference time and time again.
BooksBooks
International Combination Products
Member: $130.00 Nonmember: $180.00
This book provides an in-depth look at this breakthrough field and covers three major regulatory regions – the US, Canada, and Europe.
BooksBooks
Software as a Medical Device
Member: $145.00 Nonmember: $200.00
SaMD will help readers uncover whether their software is subject to global medical device regulations, understand the regulatory implications, and develop their SaMD strategy.
BooksBooks
Global Medical Device Regulatory Strategy, Second Edition
Member: $205.00 Nonmember: $285.00
Learn to develop a comprehensive global regulatory strategy for medical devices, labeling, clinical, risk management, marketing, and postmarketing.
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Our pharmaceutical-related books span the entire lifecycle for medicinal products from clinical trial application to dossier preparation and on through postmarketing activities and requirements. These outstanding resources will benefit individuals working in multinational pharmaceutical and biologics product development and marketing at all levels.

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E-booksE-books
Nutrition, Health, and Disease: Regulatory Policy Matters
Member: $145.00 Nonmember: $200.00
This book depicts the importance of nutrition and the gut microbiome in noncommunicable chronic diseases (NCD) prevention and management.
E-booksE-books
Postapproval Changes for Drugs: A Practical Guide (e-book)
Member: $160.00 Nonmember: $225.00
This guide covers postapproval changes from marketing authorization transfers, administrative changes, late phase renewals through to additional indications.
BooksBooks
Regulation of Regenerative Medicines: A Global Perspective
Member: $145.00 Nonmember: $200.00
Regulation of Regenerative Medicines: A Global Perspective takes a look inside the rapidly evolving cell therapy, gene therapy, and tissue engineering landscape in the US and other key world markets.
E-booksE-books
Quality Management Systems for Drugs and Devices (e-book)
Member: $205.00 Nonmember: $285.00
Quality Management Systems for Drugs and Devices presents a comprehensive overview of quality management systems, including quality assurance, GMP, GLP, GCP, and compliance.
BooksBooks
Global Pediatric Development of Drugs, Biologics, and Medical Devices
Member: $130.00 Nonmember: $180.00
This book takes a comprehensive look at global regulations, guidance, and incentives for the development of products for the pediatric population.
E-booksE-books
Orphan Drug Development for Rare Diseases (e-book)
Member: $130.00 Nonmember: $180.00
Orphan Drug Development for Rare Diseases covers every aspect of orphan drug development. Topics include incentives, benefits, patient engagement, designation, marketing authorization, and market access.
BooksBooks
Lifecycle Management Through the Rx-to-OTC Switch
Member: $145.00 Nonmember: $200.00
Lifecycle Management Through the Rx-to-OTC Switch is a must read for anyone involved in or responsible for understanding the regulatory requirements and developmental stages of a successful switch program.
BooksBooks
International Combination Products
Member: $130.00 Nonmember: $180.00
This book provides an in-depth look at this breakthrough field and covers three major regulatory regions – the US, Canada, and Europe.
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RAPS’ broad collection of biotechnology resources offers the latest on global regulations and legislation governing products derived from biotechnology, including biosimilars, vaccines, and biologics. Topics include product labeling, promotion, REMS, regulatory intelligence, and more.

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BooksBooks
Regulation of Regenerative Medicines: A Global Perspective
Member: $145.00 Nonmember: $200.00
Regulation of Regenerative Medicines: A Global Perspective takes a look inside the rapidly evolving cell therapy, gene therapy, and tissue engineering landscape in the US and other key world markets.
BooksBooks
Global Pediatric Development of Drugs, Biologics, and Medical Devices
Member: $130.00 Nonmember: $180.00
This book takes a comprehensive look at global regulations, guidance, and incentives for the development of products for the pediatric population.
E-booksE-books
Orphan Drug Development for Rare Diseases (e-book)
Member: $130.00 Nonmember: $180.00
Orphan Drug Development for Rare Diseases covers every aspect of orphan drug development. Topics include incentives, benefits, patient engagement, designation, marketing authorization, and market access.
BooksBooks
International Combination Products
Member: $130.00 Nonmember: $180.00
This book provides an in-depth look at this breakthrough field and covers three major regulatory regions – the US, Canada, and Europe.
BooksBooks
Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition
Member: $160.00 Nonmember: $225.00
This book presents a systematic approach to creating a global strategy to meet the requirements of multiple regulatory systems.
BooksBooks
Essentials of Healthcare Product Labeling
Member: $130.00 Nonmember: $180.00
Learn details on labeling for the full lifecycle of human healthcare products, from target labeling through submission and marketing in the US, EU and Canada.
BooksBooks
Promotion of FDA-Regulated Medical Products
Member: $130.00 Nonmember: $180.00
This book expands on RAPS’ 2013 publication, FDA Requirements for Prescription Drug Promotion by John Driscoll, to include prescription devices.
BooksBooks
Risk Evaluation and Mitigation Strategies for US Drug Development, Second Edition by Edward Tabor, MD
Member: $37.50 Nonmember: $62.50
A comprehensive analysis FDA’s REMS program, including insight from new guidance documents and recent REMS approvals.
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RAPS has curated a collection of business and career development tools that will enhance your skills, improve financial performance and leadership development, and sharpen your writing, communication, and negotiation skills.

BooksBooks
Regulatory Writing: An Overview, Second Edition
Member: $160.00 Nonmember: $225.00
This new edition is a valuable resource for professionals engaged in designing, composing, compiling, or commenting on regulatory documentation.
BooksBooks
Introduction to the Due Diligence Process, Second Edition
Member: $75.00 Nonmember: $125.00
Explore modern elements of the due diligence process, including the changing focus of document review, and the role of regulatory counsel.
BooksBooks
Eclectic Science and Regulatory Compliance: Stories for the Curious
Member: $15.00 Nonmember: $20.00
This is an informative, enjoyable read for individuals involved in the fields of medicine and science and those with curious minds.
BooksBooks
Communication and Negotiation
Member: $15.00 Nonmember: $20.00
This book provides basic and detailed descriptions of the communication and negotiation skills necessary to achieve regulatory excellence.
BooksBooks
Choosing the Right Regulatory Career
Member: $20.00 Nonmember: $25.00
Research the diverse and demanding career options available to regulatory professionals across the industry. From traditional and alternative career pathways, explore the many ways to break into regulatory.

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Trending News »

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Books »

Fundamentals of Medical Device Regulations, Fifth Edition
Postmarket Requirements for Medical Devices: A Practical Guide (e-book)

Learning »

Sponsored webcast: Navigating the Complex IVDR Landscape (On-demand)
Sponsored Webcast: The EU Clinical Trials Regulation – Challenges Drug Developers Faced in the First 6 Months (On-Demand)

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eCTD Focused Microsoft Word and PDF Document Creation Workshop
Meet the Authors: Postmarket Requirements for Medical Devices