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Submission: On January 23 via manual from US — Scanned from US
Effective URL: https://www.raps.org/products/fundamentals-of-international-regulatory-affairs-fifth-edition?mkt_tok=MjU5LVdMVS04MDkA...
Submission: On January 23 via manual from US — Scanned from US
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<h1 id="title" itemprop="name" style="margin-top: 5px;" class="pd-header h1">Fundamentals of International Regulatory Affairs, Fifth Edition</h1><!--GN940-->
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<p><strong>Section I: General Information</strong><br> Chapter 1: Introduction to International Regulatory Affairs <br> Chapter 2: Crisis Management for the Healthcare Product Industry <br> Chapter 3: Clinical Trials,
Good Clinical Practice, Regulations, and Compliance <br> Chapter 4: In-Country Representation<br> Chapter 5: International Advertising and Promotion <br> Chapter 6: Compliance and Enforcement<br> Chapter 7:
International Counterfeit Regulations<br> Chapter 8: Regulatory Reliance <br> Chapter 9: Pricing and Reimbursement<br> Chapter 10: Health Technology Assessment (HTA) <br>
<br>
<strong>Section II: Pharmaceuticals</strong><br> Chapter 11: Premarket Requirements/Dossier Requirements<br> Chapter 12: Authorization Procedures for Pharmaceutical Products<br> Chapter 13: Stability Test Requirements<br>
Chapter 14: Quality Systems and Inspectorate Process for Pharmaceuticals<br> Chapter 15: Generic Drug Products <br> Chapter 16: Over-the-Counter (OTC) Products<br> Chapter 17: Pharmaceutical Postmarketing and Compliance<br>
<br>
<strong>Section III: Medical Devices</strong><br> Chapter 18: Medical Device Premarket Requirements<br> Chapter 19: Technical and Regulatory Requirements<br> Chapter 20: Medical Device Quality Management Systems <br>
Chapter 21: In Vitro Diagnostic Medical Devices<br> Chapter 22: Active Implantable Medical Devices<br> Chapter 23: Software <br> Chapter 24: Postmarket Requirements<br>
<br>
<strong>Section IV: Biologics</strong><br> Chapter 25: High-Risk Products: Products Derived from Biotechnology <br> Chapter 26: Biosimilars: Basics and Recent Developments <br> Chapter 27: Vaccines<br>
<br>
<strong>Section V: Other Product Classifications</strong><br> Chapter 28: Products Manufactured from Human Blood and Plasma <br> Chapter 29: Principles of Rare Diseases and Orphan Products Development<br> Chapter 30:
Combination Products <br> Chapter 31: Regulatory Considerations for Cell-Based Medicinal Products<br> Chapter 32: Food Supplements and Food for Special Medical Purposes<br> Chapter 33: Botanical Drug Products and
Traditional Medicine<br> Chapter 34: Global Pediatric Drug Development<br> Chapter 35: Cosmetic Products <br> Chapter 36: Veterinary Medicinal Products
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<p>Fundamentals of International Regulatory Affairs, Fifth Edition contains both new and updated information as international harmonization efforts continue. The book offers new chapters on regulatory reliance, pricing and
reimbursement, and health technology assessment, as well as updated chapters on cosmetic products and veterinary medical products. Updated through May 2021, this new edition discusses the many changes that have occurred globally and
technologically over the last three years, including some due to the COVID-19 pandemic. </p>
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<p>The medical device chapters examine the global regulations for devices and in vitro diagnostic devices, from premarket through postmarket and represent the state of the art in regulatory sciences. The drug chapters review the
entire lifecycle for medicinal products from clinical trial application to dossier preparation and on through postmarketing activities and requirements. They also cover products derived from biotechnology including biosimilars
and vaccines.<br>
<br> This latest edition also features a comprehensive matrix of applicable laws and regulations, a glossary of terms, abbreviations, and acronyms, and an extensive index to compliment the chapters.
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<h2>Bonus: Free E-book with Every Purchase</h2>
<div>Receive a free e-copy of the Fundamentals of International Regulatory Affairs, Fifth Edition with every purchase of the printed version. <strong>Note: The Fundamentals of International Regulatory Affairs, Fifth Edition e-book is no
longer available for purchase separately.</strong></div>
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<h2>Who should buy this book?</h2>
<div>Fundamentals of International Regulatory Affairs is an outstanding reference for individuals working in multinational 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. It also is a handy study tool for those planning to sit for the Regulatory Affairs Certification (RAC) exam, in addition to professional experience, training, and other
resources.</div>
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<h2>Related books you may be interested in:</h2>
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<li><a href="https://www.raps.org/products/the-european-medical-device-regulation-2021-update">The European Medical Device Regulation (2021 Update)</a></li>
<li><a href="https://www.raps.org/products/european-medical-device-regulation-desktop-reference-booklet">European Medical Device Regulation Desktop Reference Booklet</a></li>
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<div><br> Published by RAPS © 2021. Hardcover. 736 pages. ISBN: 978-1-947493-63-6.</div>
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">
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Lock Members Only close arrow-right cart search google-plus facebook twitter youtube flickr linkedin calendar user menu menu-close print share circle-down help briefcase latest recon star word-bubble news RAPS.org needs your explicit consent to store browser cookies. If you don't allow cookies, you may not be able to use certain features of the web site such as personalized content. Please see our Privacy Policy for more information. Skip to Main Navigation Skip to Main Content Skip to Footer 33e9d3cf-8610-4978-9f63-5c30b3bba6ec Close Login Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance. 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Get Started EDUCATION Education Events Books Courses Learning Portal Corporate Training Convergence Euro Convergence Executive Development * JUST RELEASED! POSTMARKET REQUIREMENTS FOR MEDICAL DEVICES: A PRACTICAL GUIDE This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market. Buy the book CERTIFICATION Certification My RAC Apply Prep Tools Recertify Exam Sites & Scheduling About the RAC RAC Holders RAC Spotlights * RAC SPOTLIGHTS Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey. LEARN MORE RESOURCES Resources Suppliers Guide About the Profession Careers Competency Framework Code of Ethics Scope of Practice Workforce Report * Skip to Navigation Books FUNDAMENTALS OF INTERNATIONAL REGULATORY AFFAIRS, FIFTH EDITION 0.0 RAC Credits Members: $147.50 Nonmembers: $197.50 Add Book to Cart TABLE OF CONTENTS SEE WHAT'S INSIDE » Section I: General Information Chapter 1: Introduction to International Regulatory Affairs Chapter 2: Crisis Management for the Healthcare Product Industry Chapter 3: Clinical Trials, Good Clinical Practice, Regulations, and Compliance Chapter 4: In-Country Representation Chapter 5: International Advertising and Promotion Chapter 6: Compliance and Enforcement Chapter 7: International Counterfeit Regulations Chapter 8: Regulatory Reliance Chapter 9: Pricing and Reimbursement Chapter 10: Health Technology Assessment (HTA) Section II: Pharmaceuticals Chapter 11: Premarket Requirements/Dossier Requirements Chapter 12: Authorization Procedures for Pharmaceutical Products Chapter 13: Stability Test Requirements Chapter 14: Quality Systems and Inspectorate Process for Pharmaceuticals Chapter 15: Generic Drug Products Chapter 16: Over-the-Counter (OTC) Products Chapter 17: Pharmaceutical Postmarketing and Compliance Section III: Medical Devices Chapter 18: Medical Device Premarket Requirements Chapter 19: Technical and Regulatory Requirements Chapter 20: Medical Device Quality Management Systems Chapter 21: In Vitro Diagnostic Medical Devices Chapter 22: Active Implantable Medical Devices Chapter 23: Software Chapter 24: Postmarket Requirements Section IV: Biologics Chapter 25: High-Risk Products: Products Derived from Biotechnology Chapter 26: Biosimilars: Basics and Recent Developments Chapter 27: Vaccines Section V: Other Product Classifications Chapter 28: Products Manufactured from Human Blood and Plasma Chapter 29: Principles of Rare Diseases and Orphan Products Development Chapter 30: Combination Products Chapter 31: Regulatory Considerations for Cell-Based Medicinal Products Chapter 32: Food Supplements and Food for Special Medical Purposes Chapter 33: Botanical Drug Products and Traditional Medicine Chapter 34: Global Pediatric Drug Development Chapter 35: Cosmetic Products Chapter 36: Veterinary Medicinal Products Sample Chapter PRODUCT DESCRIPTION Fundamentals of International Regulatory Affairs, Fifth Edition contains both new and updated information as international harmonization efforts continue. The book offers new chapters on regulatory reliance, pricing and reimbursement, and health technology assessment, as well as updated chapters on cosmetic products and veterinary medical products. Updated through May 2021, this new edition discusses the many changes that have occurred globally and technologically over the last three years, including some due to the COVID-19 pandemic. Read more » The medical device chapters examine the global regulations for devices and in vitro diagnostic devices, from premarket through postmarket and represent the state of the art in regulatory sciences. The drug chapters review the entire lifecycle for medicinal products from clinical trial application to dossier preparation and on through postmarketing activities and requirements. They also cover products derived from biotechnology including biosimilars and vaccines. This latest edition also features a comprehensive matrix of applicable laws and regulations, a glossary of terms, abbreviations, and acronyms, and an extensive index to compliment the chapters. -------------------------------------------------------------------------------- BONUS: FREE E-BOOK WITH EVERY PURCHASE Receive a free e-copy of the Fundamentals of International Regulatory Affairs, Fifth Edition with every purchase of the printed version. Note: The Fundamentals of International Regulatory Affairs, Fifth Edition e-book is no longer available for purchase separately. -------------------------------------------------------------------------------- WHO SHOULD BUY THIS BOOK? Fundamentals of International Regulatory Affairs is an outstanding reference for individuals working in multinational 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. It also is a handy study tool for those planning to sit for the Regulatory Affairs Certification (RAC) exam, in addition to professional experience, training, and other resources. -------------------------------------------------------------------------------- RELATED BOOKS YOU MAY BE INTERESTED IN: * The European Medical Device Regulation (2021 Update) * European Medical Device Regulation Desktop Reference Booklet Published by RAPS © 2021. Hardcover. 736 pages. ISBN: 978-1-947493-63-6. 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