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 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.
This edition of Fundamentals of EU Regulatory Affairs focuses on changes to healthcare product development, manufacturing and marketing across the EU. The most significant changes since the introduction of the Medical Devices Directive are coming with the implementation of the EU Medical Device Regulation and EU In Vitro Diagnostic Device Regulation. Clinical trial regulations implementation has been delayed, but its impact is discussed.
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There are several new chapters in this edition, covering EMA and other EU regulatory bodies, preparing for EMA meetings, regulatory strategy, medical device preclinical testing, adaptive and alternative medicinal product pathways and more. This book is an excellent reference for anyone at any level working in regulatory affairs in the EU market and a useful tool for those planning to sit for the RAC (EU) exam.
Fundamentals of International Regulatory Affairs, Third Edition, has been revamped and updated to reflect changes in the three years since the second edition was published. More than two dozen authors from around the world contributed to the new book, adding new information on all areas of the regulated healthcare product industry. A new feature in this edition is a chapter on regenerative medicine.
This is an excellent reference book for anyone working in international markets. It also is a useful study tool for those planning to sit for the Global RAC exam. With the world of technology, health and medicine changing daily, regulatory professionals require a reference resource that stays on the competitive-edge of the industry. For regulatory pros working on products for the Canadian market, there’s no better resource than RAPS’ Fundamentals of Canadian Regulatory Affairs, Fourth Edition. Recently updated and expanded to include topics of increasing importance, this volume is the cornerstone of the Canadian regulatory professional’s reference library.