All Books and E-books

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Nutrition, Health, and Disease: Regulatory Policy Matters
Nutrition, Health, and Disease: Regulatory Policy Matters
0.0RAC Credits
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.
European Medical Device Regulation Desktop Reference Booklet
European Medical Device Regulation Desktop Reference Booklet
0.0RAC Credits
Member: $70.00 Nonmember: $100.00
Fundamentals of US Regulatory Affairs, 11th Edition (2022 Update)
Fundamentals of US Regulatory Affairs, 11th Edition (2022 Update)
0.0RAC Credits
Member: $205.00 Nonmember: $275.00
This 11th edition presents information covering all lifecycle stages of regulated healthcare products in the US.
Postapproval Changes for Drugs: A Practical Guide (e-book)
Postapproval Changes for Drugs: A Practical Guide (e-book)
0.0RAC Credits
Member: $160.00 Nonmember: $225.00
This guide covers postapproval changes from marketing authorization transfers, administrative changes, late phase renewals through to additional indications.
Fundamentals of Medical Device Regulations, Fifth Edition
Fundamentals of Medical Device Regulations, Fifth Edition
0.0RAC Credits
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.
Regulation of Regenerative Medicines: A Global Perspective
Regulation of Regenerative Medicines: A Global Perspective
0.0RAC Credits
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.
Quality Management Systems for Drugs and Devices (e-book)
Quality Management Systems for Drugs and Devices (e-book)
0.0RAC Credits
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.
Global Pediatric Development of Drugs, Biologics, and Medical Devices
Global Pediatric Development of Drugs, Biologics, and Medical Devices
0.0RAC Credits
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.
Orphan Drug Development for Rare Diseases (e-book)
Orphan Drug Development for Rare Diseases (e-book)
0.0RAC Credits
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.
Lifecycle Management Through the Rx-to-OTC Switch
Lifecycle Management Through the Rx-to-OTC Switch
0.0RAC Credits
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.
Fundamentals of Pharmaceutical and Biologics Regulations, Fourth Edition
Fundamentals of Pharmaceutical and Biologics Regulations, Fourth Edition
0.0RAC Credits
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).
Fundamentals of International Regulatory Affairs, Fifth Edition
Fundamentals of International Regulatory Affairs, Fifth Edition
0.0RAC Credits
Members: $295 Nonmembers: $395
This edition discusses regulatory changes that have occurred globally and technologically with a focus on drugs and medical devices.
The European Medical Device Regulation (2021 Update)
The European Medical Device Regulation (2021 Update)
0.0RAC Credits
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.
International Combination Products
International Combination Products
0.0RAC Credits
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.
Software as a Medical Device
Software as a Medical Device
0.0RAC Credits
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.
Regulatory Intelligence 101, Third Edition (e-book)
Regulatory Intelligence 101, Third Edition (e-book)
0.0RAC Credits
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.
Regulatory Writing: An Overview, Second Edition
Regulatory Writing: An Overview, Second Edition
0.0RAC Credits
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.
Global Medical Device Regulatory Strategy, Second Edition
Global Medical Device Regulatory Strategy, Second Edition
0.0RAC Credits
Member: $205.00 Nonmember: $285.00
Learn to develop a comprehensive global regulatory strategy for medical devices, labeling, clinical, risk management, marketing, and postmarketing.
The European In Vitro Diagnostic Regulation
The European In Vitro Diagnostic Regulation
0.0RAC Credits
Member: $295.00 Nonmember: $395.00
RAPS has teamed up with Meddev Solutions to offer a practical guide to implementing the EU IVDR.
Introduction to the Due Diligence Process, Second Edition
Introduction to the Due Diligence Process, Second Edition
0.0RAC Credits
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.
Fundamentals of EU Regulatory Affairs, Ninth Edition
Fundamentals of EU Regulatory Affairs, Ninth Edition
0.0RAC Credits
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.
Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition
Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition
0.0RAC Credits
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.
Essentials of Healthcare Product Labeling
Essentials of Healthcare Product Labeling
0.0RAC Credits
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.
Fundamentals of Canadian Pharmaceutical, Biologic and Medical Devices Regulations
Fundamentals of Canadian Pharmaceutical, Biologic and Medical Devices Regulations
0.0RAC Credits
Member: $100.00 Nonmember: $150.00
A compilation of Fundamentals of Canadian Pharmaceutical and Biologics Regulations and Fundamentals of Canadian Medical Device Regulations.
Promotion of FDA-Regulated Medical Products
Promotion of FDA-Regulated Medical Products
0.0RAC Credits
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.
Risk Evaluation and Mitigation Strategies for US Drug Development, Second Edition by Edward Tabor, MD
Risk Evaluation and Mitigation Strategies for US Drug Development, Second Edition by Edward Tabor, MD
0.0RAC Credits
Member: $37.50 Nonmember: $62.50
A comprehensive analysis FDA’s REMS program, including insight from new guidance documents and recent REMS approvals.
The Medical Device Validation Handbook, Second Edition
The Medical Device Validation Handbook, Second Edition
0.0RAC Credits
Member: $205.00 Nonmember: $285.00
The handbook covers device validation and revalidation throughout the product lifecycle, from design through postmarket.
Risk Management Principles for Devices and Pharmaceuticals
Risk Management Principles for Devices and Pharmaceuticals
0.0RAC Credits
Member: $130.00 Nonmember: $180.00
Expanded and updated risk management information on healthcare products around the world.
EU Regulatory Acronyms & Definitions, Sixth Edition
EU Regulatory Acronyms & Definitions, Sixth Edition
0.0RAC Credits
Member : $10.00 Nonmember: $15.00
An EU reference guide with entries in biologics, medicinal products, and medical devices.
International Regulatory Acronyms & Definitions, Third Edition
International Regulatory Acronyms & Definitions, Third Edition
0.0RAC Credits
Member: $10.00 Nonmember: $15.00
International regulatory terms, definitions, and acronyms that will help you develop a better understanding of international regulations.
Canadian Regulatory Acronyms & Definitions, Fifth Edition
Canadian Regulatory Acronyms & Definitions, Fifth Edition
0.0RAC Credits
Member: $10.00 Nonmember: $15.00
For those working in the Canadian market, entries of significance to the Canadian healthcare product industry.
Eclectic Science and Regulatory Compliance: Stories for the Curious
Eclectic Science and Regulatory Compliance: Stories for the Curious
0.0RAC Credits
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.
Fundamentals of Japanese Regulatory Affairs, Second Edition (Japanese language)
Fundamentals of Japanese Regulatory Affairs, Second Edition (Japanese language)
0.0RAC Credits
Member: $55.00 Nonmember: $75.00
This Japanese language version covers premarket and postmarket requirements for healthcare products.
Complete GHTF Guidance Document Bundle
Complete GHTF Guidance Document Bundle
0.0RAC Credits
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.
Complete WHO Guidance Document Bundle
Complete WHO Guidance Document Bundle
0.0RAC Credits
Member: $15.00 Nonmember: $22.50
A WHO bundle with six guidance documents addressing pharmaceuticals, medical devices, psychotropic substances and plasma.
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All Courses

Sponsored webcast: Navigating the Complex IVDR Landscape (On-demand)
Sponsored webcast: Navigating the Complex IVDR Landscape (On-demand)
1.0RAC Credits
Member: $0 | NonMember: $20
This webinar will look closely at the requirements of the EU IVDR, timelines and deadlines and common pitfalls of technical documentation.
Mastering your 510(k) submission process (On-Demand)
Mastering your 510(k) submission process (On-Demand)
1.0RAC Credits
$0 / $25
Understand the optimal pathway to follow for right-first-time, stress-free 510(k) clearance Learn the most common mistakes the FDA sees in applications, and how to avoid them Unpick the key ingredients of a 510(k) submission.
Sponsored Webcast: Orphan Drug Designation | The Considerations, The Rewards, and How They Differ Between The US and Europe (On-Demand)
Sponsored Webcast: Orphan Drug Designation | The Considerations, The Rewards, and How They Differ Between The US and Europe (On-Demand)
1.0RAC Credits
Member: $0 | NonMember: $25
Explore how the latest industry guidance, from the Case for Quality to GAMP 5 Version 2, prioritizes quality over compliance - and why
Sponsored webcast: Quality vs. compliance: moving beyond standards (On-Demand)
Sponsored webcast: Quality vs. compliance: moving beyond standards (On-Demand)
1.0RAC Credits
Member: $0 | NonMember: $25
Explore how the latest industry guidance, from the Case for Quality to GAMP 5 Version 2, prioritizes quality over compliance - and why
Sponsored webcast: Retrospective analysis of FDA’s Accelerated Approvals and conversions (On-Demand)
Sponsored webcast: Retrospective analysis of FDA’s Accelerated Approvals and conversions (On-Demand)
1.0RAC Credits
Member: $0 | NonMember: $20
This session will cover a comprehensive analysis of the Accelerated Approval program as well as a deep dive into a selection of past examples and precedents.
Sponsored Webcast: A Regulatory and Strategic Framework for Facilitating Pediatric Drug Development (On-Demand)
Sponsored Webcast: A Regulatory and Strategic Framework for Facilitating Pediatric Drug Development (On-Demand)
1.0RAC Credits
Member: $0 | Nonmember: $20
During the webinar, pediatric development experts will provide an overview of the global regulatory framework and requirements that drive pediatric development.
Pharmaceutical Labeling: Introduction to an Essential Function
Pharmaceutical Labeling: Introduction to an Essential Function
2.0RAC Credits
Member: $255.00 Nonmember: $350.00
This course is designed to expand the understanding of regulatory professionals about the activities, documents, and responsibilities involved in labeling healthcare products.
FDA QMSR: What do the Proposed Changes Mean for Industry? (On-Demand)
FDA QMSR: What do the Proposed Changes Mean for Industry? (On-Demand)
1.0RAC Credits
Member: $0 | NonMember: $25
Speakers will review the history of quality systems, look at the changes to quality regulations and discuss the FDA’s intent to adopt the ISO 13485 standard.
Postmarket Clinical Follow-up Under MDR (On-Demand)
Postmarket Clinical Follow-up Under MDR (On-Demand)
1.0RAC Credits
Member: $0 NonMember: $25
This free webcast will provide an overview of how to plan and execute the PMCF requirements under MDR, taking into consideration key factors such as novelty, longevity on the market, and risk classification.
Audits and Inspections: How to Drive a Standardization Strategy that Sticks (On-Demand)
Audits and Inspections: How to Drive a Standardization Strategy that Sticks (On-Demand)
1.0RAC Credits
Member: $0 NonMember: $25
Audits and inspections: how to drive a standardization strategy that sticks
Ensure Your MDR Program is State of the Art (On-Demand)
Ensure Your MDR Program is State of the Art (On-Demand)
1.5RAC Credits
Member:$0 NonMember:$25
This webcast will cover how this definition in context of the formal MDR and MEDDEV references impacts technical documentation, risk analysis, clinical, and postmarket documentation.
Sponsored Webcast: Smarter Clinical Document Automation Now for your T&D Requirements Later (On-Demand)
Sponsored Webcast: Smarter Clinical Document Automation Now for your T&D Requirements Later (On-Demand)
1.0RAC Credits
Member: $0 NonMember: $25
This webcast will illustrate how automation through the use of advanced technology allows for the production of clinical documents with future disclosure in mind.
Sponsored Webcast: EU IVDR: Intriguing Insights, Recommended Actions, and a Look Towards the Future
Sponsored Webcast: EU IVDR: Intriguing Insights, Recommended Actions, and a Look Towards the Future
1.0RAC Credits
Member: $0 NonMember: $25
Leveraging notified body expertise and real life industry feedback, this webcast is designed to reflect on lessons learned under the IVDR and discuss what the future may look like for diagnostics in Europe.
Meet the Authors: Regulation of Regenerative Medicine: A Global Perspective
Meet the Authors: Regulation of Regenerative Medicine: A Global Perspective
1.0RAC Credits
Price: $0
Hear from the authors who wrote RAPS' latest book, Regulation of Regenerative Medicine: A Global Perspective. Regenerative medicine is a growing field with more countries focused on generating governing regulations.
Sponsored Webcast: What is FDA's Project Optimus and How Will it Impact Oncology Drug Development? (On-Demand)
Sponsored Webcast: What is FDA's Project Optimus and How Will it Impact Oncology Drug Development? (On-Demand)
1.0RAC Credits
Member: $0 NonMember: $25
This webinar will provide information on FDA’s Project Optimus and its potential impacts on oncology drug development.
Sponsored Webcast: Building Compliance with an Electronic Quality Management System (On-Demand)
Sponsored Webcast: Building Compliance with an Electronic Quality Management System (On-Demand)
1.5RAC Credits
Member: $0 NonMember: $25
Learn to leverage electronic QMS systems to build compliance. This live broadcast will debunk QMS myths and address the challenges in ensuring data integrity.
2021 China NMPA (CFDA) Key Updates and 2022 Forecast (On-Demand)
2021 China NMPA (CFDA) Key Updates and 2022 Forecast (On-Demand)
1.0RAC Credits
Members: $0 | Nonmembers: $25
This webcast will show how manufacturers can expedite the path to market for new China NMPA submissions. It will cover Order 739, when to file for modifications, how to keep medical devices compliant, and more.
Sponsored Webcast: eCTD Submission Challenges (On-Demand)
Sponsored Webcast: eCTD Submission Challenges (On-Demand)
1.0RAC Credits
Members: $0 | Nonmembers: $25
Regulatory operations specialist Joshua Lett will explore how challenges in eCTD submissions may provide opportunities for personal and professional growth.
Sponsored Webcast: Why UDI is a Regulatory Issue and Not Just an Operational Process  (On-Demand)
Sponsored Webcast: Why UDI is a Regulatory Issue and Not Just an Operational Process (On-Demand)
1.0RAC Credits
Members: $0 | Nonmembers: $25
Simplify UDI complexity by exploring requirements across several major markets, including the types of devices that are covered and the expected implementation timelines.
COVID-19 EUAs: The Beginning of the End
COVID-19 EUAs: The Beginning of the End
1.5RAC Credits
Member: $0 NonMember: $25
The authors of RAPS new regulatory reference guide, Orphan Drug Development for Rare Diseases, will be on hand to discuss every aspect of orphan drug development.