All Books and E-books

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Postmarket Requirements for Medical Devices: A Practical Guide (e-book)
Postmarket Requirements for Medical Devices: A Practical Guide (e-book)
0.0RAC Credits
Member: $175 Nonmember: $245
Comprehensive guide covering product change evaluation, postmarket surveillance, and compliance with audit/inspection requirements in the medical device industry.
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: $147.50 Nonmember: $197.50
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: $147.50 Nonmembers: $197.50
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: $147.50 Nonmembers: $197.50
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.
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All Courses

China Drug Registration and Reimbursement (On-Demand)
China Drug Registration and Reimbursement (On-Demand)
1.5RAC Credits
Member: $0 | NonMember: $25
This webcast will present information on how to register your drug in China and how pricing or market access is determined. What is the best strategy to register and maximize pricing in China.
RAPS Webcast: Optimizing Standards for Regulatory Use (On-Demand)
RAPS Webcast: Optimizing Standards for Regulatory Use (On-Demand)
1.0RAC Credits
Price: $0 Member | $25 NonMember
This webcast will feature an FDA presentation on how consensus standards can be improved in order to better allow manufacturers to cite them appropriately in device submissions.
RAPS Webcast: Streamlining Conformity Assessment in Device Submissions: FDA’s ASCA Program (On-Demand)
RAPS Webcast: Streamlining Conformity Assessment in Device Submissions: FDA’s ASCA Program (On-Demand)
1.0RAC Credits
Member: $0 | NonMember: $25
Introductory webcast for participants to the webcast for participants to the FDA's ASCA, a program in which manufacture.rs may contract with ASCA-accredited test labs to perform testing to certain consensus standards
2022 NMPA (CFDA) Key Updates and Look Ahead (On-Demand)
2022 NMPA (CFDA) Key Updates and Look Ahead (On-Demand)
1.0RAC Credits
Member: $0 | NonMember: $25
In this webcast, key policies, guidelines, and standards will be reviewed. Manufacturers and Inventors can implement techniques to shorten their time to market.
Standards in Medical Device Submissions: Practical Advice on Appropriately Citing Consensus Standards to Reduce Regulatory Burden (On-Demand)
Standards in Medical Device Submissions: Practical Advice on Appropriately Citing Consensus Standards to Reduce Regulatory Burden (On-Demand)
1.0RAC Credits
This webcast will explain the importance of consensus standards in medical device development and offer practical direction to device firms' regulatory affairs and standards staff about how to correctly cite standards in their submissions.
RAPS Webcast: Overview PMS Key Updates: China QMS/GMP Compliance per Order 739 (On-Demand)
RAPS Webcast: Overview PMS Key Updates: China QMS/GMP Compliance per Order 739 (On-Demand)
1.0RAC Credits
Member: $0 | NonMember: $25
This webcast recording will teach you about updated requirements in GMP and post market supervision for State Order 739: “Regulations on Supervision and Administration of Medical Devices"
FDA Forecast: What's Next for the FDA in 2023? (On-Demand)
FDA Forecast: What's Next for the FDA in 2023? (On-Demand)
1.5RAC Credits
Member: $0 | NonMember: $25
What will the FDA do in 2023? In this timely, lively and informative event, regulatory analysts from POLITICO's AgencyIQ will explain what regulatory professionals should anticipate in the year ahead.
Meet the Authors: Postmarket Requirements for Medical Devices (On-Demand)
Meet the Authors: Postmarket Requirements for Medical Devices (On-Demand)
1.0RAC Credits
Price: Free
Come meet the lead authors of RAPS latest e-book, Postmarket Requirements for Medical Devices: A Practical Guide. Hear first hand why the book was developed, who the book was developed for, and how you can benefit from reading it
Sponsored webcast: Navigating the Complex IVDR Landscape (On-demand)
Sponsored webcast: Navigating the Complex IVDR Landscape (On-demand)
1.0RAC Credits
Member: $0 | NonMember: $25
This webinar will look closely at the requirements of the EU IVDR, timelines and deadlines and common pitfalls of technical documentation.
Sponsored Webcast: The EU Clinical Trials Regulation – Challenges Drug Developers Faced in the First 6 Months (On-Demand)
Sponsored Webcast: The EU Clinical Trials Regulation – Challenges Drug Developers Faced in the First 6 Months (On-Demand)
1.0RAC Credits
Member: $0 | NonMember: $25
In this webinar, Certara experts Gabriella Mangino and Anaya Rehman will talk through the changes and lessons learned nearly 6 months after CTIS was implemented.
Sponsored webcast: Rapid Sharing of International Clinical Data Ensuring Patient Privacy for Combating Pandemics and Other Diseases (On-Demand)
Sponsored webcast: Rapid Sharing of International Clinical Data Ensuring Patient Privacy for Combating Pandemics and Other Diseases (On-Demand)
1.0RAC Credits
Member: $0 | NonMember: $25
In this webinar, Certara experts Gabriella Mangino and Anaya Rehman will talk through the changes and lessons learned nearly 6 months after CTIS was implemented.
Mastering your 510(k) submission process (On-Demand)
Mastering your 510(k) submission process (On-Demand)
1.0RAC Credits
Member: $0 | Nonmember: $25
Understand the optimal pathway to follow for right-first-time, stress-free 510(k) clearance.
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
Meet the Authors: Nutrition, Health, and Disease: Regulatory Policy Matters (On-Demand)
Meet the Authors: Nutrition, Health, and Disease: Regulatory Policy Matters (On-Demand)
1.0RAC Credits
Free
Meet our author and ask questions about RAPS' latest e-book, Nutrition, Health, and Disease: Regulatory Policy Matters.
Sponsored Webcast: Is Your Labeling an Adverse Event Waiting to Happen? (On-Demand)
Sponsored Webcast: Is Your Labeling an Adverse Event Waiting to Happen? (On-Demand)
1.0RAC Credits
Price: Member: $0 | NonMember: $25
In this session we’ll explore compliant labeling, examine labeling process gaps, and provide you with the tools to defend a robust labeling process at your organization.
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: $25
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: $25
During the webinar, pediatric development experts will provide an overview of the global regulatory framework and requirements that drive pediatric development.
RAC Devices Examination Autumn 2023
RAC Devices Examination Autumn 2023
0.0RAC Credits
Member: $495.00 Nonmember: $625.00
Testing Window :
30 October 2023 To 8 December 2023
Registration Deadline : 5 October 2023
RAC Devices Examination Spring 2023
RAC Devices Examination Spring 2023
0.0RAC Credits
Member: $495.00 Nonmember: $625.00
Testing Window : 20 March 2023 To 28 April 2023
Registration Deadline : 23 February 2023