Books Catalog

Starting Friday, 26 November through Monday, 29 November, save 20% on all books and e-books with discount code CYBERMONDAY20*.

Become a RAPS member or renew your membership between 26–29 November and receive a complimentary e-book of your choosing (up to a $175 value). Join RAPS »

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.

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Books Books
Fundamentals of Medical Device Regulations, Fourth Edition (Hardcover)
Member: $295.00 Nonmember: $395.00
Bundle includes the individual medical device subsets from all four Fundamentals of Regulatory Affairs books (US, EU, Canada, international).
Books Books
Fundamentals of Pharmaceutical and Biologics Regulations, Fourth Edition (Hardcover)
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).
Books Books
Fundamentals of International Regulatory Affairs, Fifth Edition (Hardcover)
Members: $295 Nonmembers: $395
This edition discusses regulatory changes that have occurred globally and technologically with a focus on drugs and medical devices.
Books Books
Fundamentals of EU Regulatory Affairs, Ninth Edition (Hardcover)
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.
Books Books
Fundamentals of US Regulatory Affairs, 11th Edition (Hardcover)
Member: $295.00 Nonmember: $395.00
This 11th edition presents information covering all lifecycle stages of regulated healthcare products in the US.
Books Books
Fundamentals of Canadian Pharmaceutical, Biologic and Medical Devices Regulations (Hardcover)
Member: $100.00 Nonmember: $150.00
A compilation of Fundamentals of Canadian Pharmaceutical and Biologics Regulations and Fundamentals of Canadian Medical Device Regulations.
Books Books
Fundamentals of Japanese Regulatory Affairs, Second Edition (Japanese language) (Paperback)
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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Books Books
The European Medical Device Regulation (2021 Update) (Paperback)
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.
Books Books
International Combination Products (Paperback)
Member: $125.00 Nonmember: $175.00
This book provides an in-depth look at this breakthrough field and covers three major regulatory regions – the US, Canada, and Europe.
Books Books
Software as a Medical Device (Paperback)
Member: $125.00 Nonmember: $175.00
SaMD will help readers uncover whether their software is subject to global medical device regulations, understand the regulatory implications, and develop their SaMD strategy.
Books Books
Regulatory Intelligence 101, Third Edition (Paperback)
Member: $125.00 Nonmember: $175.00
Comprised of 25 chapters from 30 experts from seven different countries, this new edition incorporates a global overview of regulatory intelligence.
Books Books
Global Medical Device Regulatory Strategy, Second Edition (Hardcover)
Member: $125 Nonmember: $175
Learn to develop a comprehensive global regulatory strategy for medical devices, labeling, clinical, risk management, marketing, and postmarketing.
Books Books
The European In Vitro Diagnostic Regulation (Paperback)
Member: $295.00 Nonmember: $395.00
RAPS has teamed up with Meddev Solutions to offer a practical guide to implementing the EU IVDR.
Books Books
Essentials of Healthcare Product Labeling (Paperback)
Member: $125.00 Nonmember: $175.00
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.
Books Books
Promotion of FDA-Regulated Medical Products (Paperback)
Member: $125.00 Nonmember: $175.00
This book expands on RAPS’ 2013 publication, FDA Requirements for Prescription Drug Promotion by John Driscoll, to include prescription devices.
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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-books E-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.
Books Books
Lifecycle Management Through the Rx-to-OTC Switch (Paperback)
Member: $125.00 Nonmember: $175.00
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.
Books Books
International Combination Products (Paperback)
Member: $125.00 Nonmember: $175.00
This book provides an in-depth look at this breakthrough field and covers three major regulatory regions – the US, Canada, and Europe.
Books Books
Regulatory Intelligence 101, Third Edition (Paperback)
Member: $125.00 Nonmember: $175.00
Comprised of 25 chapters from 30 experts from seven different countries, this new edition incorporates a global overview of regulatory intelligence.
Books Books
Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition (Hardcover)
Member: $125 Nonmember: $175
This book presents a systematic approach to creating a global strategy to meet the requirements of multiple regulatory systems.
Books Books
Essentials of Healthcare Product Labeling (Paperback)
Member: $125.00 Nonmember: $175.00
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.
Books Books
Promotion of FDA-Regulated Medical Products (Paperback)
Member: $125.00 Nonmember: $175.00
This book expands on RAPS’ 2013 publication, FDA Requirements for Prescription Drug Promotion by John Driscoll, to include prescription devices.
Books Books
Risk Evaluation and Mitigation Strategies for US Drug Development, Second Edition by Edward Tabor, MD (Paperback)
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’ 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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E-books E-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.
Books Books
International Combination Products (Paperback)
Member: $125.00 Nonmember: $175.00
This book provides an in-depth look at this breakthrough field and covers three major regulatory regions – the US, Canada, and Europe.
Books Books
Regulatory Intelligence 101, Third Edition (Paperback)
Member: $125.00 Nonmember: $175.00
Comprised of 25 chapters from 30 experts from seven different countries, this new edition incorporates a global overview of regulatory intelligence.
Books Books
Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition (Hardcover)
Member: $125 Nonmember: $175
This book presents a systematic approach to creating a global strategy to meet the requirements of multiple regulatory systems.
Books Books
Essentials of Healthcare Product Labeling (Paperback)
Member: $125.00 Nonmember: $175.00
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.
Books Books
Promotion of FDA-Regulated Medical Products (Paperback)
Member: $125.00 Nonmember: $175.00
This book expands on RAPS’ 2013 publication, FDA Requirements for Prescription Drug Promotion by John Driscoll, to include prescription devices.
Books Books
Risk Evaluation and Mitigation Strategies for US Drug Development, Second Edition by Edward Tabor, MD (Paperback)
Member: $37.50 Nonmember: $62.50
A comprehensive analysis FDA’s REMS program, including insight from new guidance documents and recent REMS approvals.
Books Books
EU Regulatory Acronyms & Definitions, Sixth Edition (Paperback)
Member : $10.00 Nonmember: $15.00
An EU reference guide with entries in biologics, medicinal products, and medical devices.
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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.

Books Books
Regulatory Writing: An Overview, Second Edition (Hardcover)
Member: $125.00 Nonmember: $175.00
This new edition is a valuable resource for professionals engaged in designing, composing, compiling, or commenting on regulatory documentation.
Books Books
Introduction to the Due Diligence Process, Second Edition (Paperback)
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.
Books Books
Eclectic Science and Regulatory Compliance: Stories for the Curious (Paperback)
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.
Books Books
From Alzheimer's to Zebrafish: Eclectic Science and Regulatory Stories (Paperback)
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.
Books Books
Communication and Negotiation (Paperback)
Member: $15.00 Nonmember: $20.00
This book provides basic and detailed descriptions of the communication and negotiation skills necessary to achieve regulatory excellence.
Books Books
Choosing the Right Regulatory Career (Paperback)
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.

* RAPS Cyber Monday sale begins at 12:01 am on Friday, 26 November and ends at 11:59 PM EST on Monday, 29 November 2021. Offer may not be combined with any other promotions or discounts and may not be applied to prior purchases. 20% off promotion EXCLUDES RAPS Executive Development Program, RAC exam registration, RAC toolboxes, RAC prep bundles, individual RAC prep materials, RAPS Convergence, RAPS Euro Convergence, and RAPS live virtual programs.

Instructions for redeeming the promotional e-book offered with RAPS memberships and renewals purchased during the Cyber Monday sale will be included in the purchase receipt. This promotion is valid for a one-time download of an e-book valued up to $175 and expires at 11:59 PM EST on 31 December 2021.

Have questions? Please contact the RAPS solutions center by email at support@raps.org or by calling 301-770-2920 extension 200.