Fundamentals of us regulatory affairs

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fundamentals of us regulatory affairs

Fundamentals of US Regulatory Affairs by Regulatory Affairs Professionals Society (RAPS)

The cornerstone product for the regulatory affairs industry, this book is used as an essential training tool at many prominent healthcare organizations, a mandatory text in many university-level courses and the most popular reference tool in preparing for the RAC (US) Exam. The new edition has been updated to reflect the current regulatory requirements for the US Food and Drug Administration (FDA) and other state and federal agencies, and covers the full range of established regulatory requirements across product lines and throughout the product lifecycle. The 33 chapters are categorized into topic-specific sections, allowing you to quickly find the information you need. There are new chapters on Drug, Biologic and Device Regulatory Pathways; FDA Communications and Meetings; Patents and Exclusivity; and Veterinary Products. This product is a recommended reference tool in preparing for the RAC (US) Exam and is available in a variety of discounted reference packages.
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Published 05.06.2019

FDA Regulatory Affairs Webinar - Asphalion

RAPS' Fundamentals of Regulatory Affairs series puts all the information you need right at your fingertips. These books are not just for new regulatory.
Regulatory Affairs Professionals Society (RAPS)

ISBN 13: 9780982932063

The site navigation utilizes arrow, enter, escape, and space bar key commands. Up and Down arrows will open main level menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab will move on to the next part of the site rather than go through menu items. The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals. One of our most valuable contributions to the profession is the Regulatory Code of Ethics.

First published 20 years ago, the book has become an important reference for regulatory professionals and others working with healthcare products regulated by the US Food and Drug Administration FDA and other US agencies.
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First published 20 years ago, the book has become an important reference for regulatory professionals and others working with healthcare products regulated by the US Food and Drug Administration FDA and other US agencies. The internet offers a wealth of information but being able to find and gather reliable and actionable information from multiple different sources is time- and labor-intensive. The reason this book is still so valuable is that it is the only reference that compiles such comprehensive US regulatory affairs knowledge in one place. Fundamentals of US Regulatory Affairs has undergone multiple revisions over its 11 editions, encompassing new regulations, new technologies and the constantly evolving practice of healthcare. Fundamentals of US Regulatory Affairs, 11th Edition includes more than 1, updates on regulations, legislation and agency guidances, and all information is current as of April This edition includes 39 chapters by 54 expert authors, as well as an extensive matrix of regulations across product lines that has been completely revamped. New in this edition are two separate indexes—one on laws and guidances and one organized by subject matter, a new chapter on master protocol and comprehensively updated chapters on pediatrics, traceability and supply chain, and FDA user fees.

The site navigation utilizes arrow, enter, escape, and space bar key commands. Up and Down arrows will open main level menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab will move on to the next part of the site rather than go through menu items. The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

5 thoughts on “Fundamentals of US Regulatory Affairs by Regulatory Affairs Professionals Society (RAPS)

  1. The first edition of US Fundamentals was introduced two decades ago and has undergone regular revisions over the years, reflecting changing regulations and new technologies.

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