<p>Since its launch in 1999, Fundamentals of US Regulatory Affairs has been RAPS' top selling publication-relied upon by those new to regulatory and trusted by seasoned professionals. The much anticipated international edition-Fundamentals of International Regulatory Affairs-is now available!Whether you are new to regulatory affairs, preparing for the RAC (General Scope) Exam or looking for a touch-up of the fundamentals in your field, the Fundamentals of International Regulatory Affairs, First Edition will serves as an excellent reference tool to put you on the right path in your career. This essential text provides a comprehensive understanding of established international regulatory requirements across product linesFeaturing: * International guidance documents from ICH, GHTF, WHO and ISO * Comparison of submission requirements around the world * Illustrative figures and tablesRegulatory students: Ask you professor about special RAPS pricing on the Fundamentals series.RAPS does not accept exchanges or returns on items that have already been shipped or emailed. Cancellations of orders must be made within 24 hours from the time the original order was placed.</p>

Fundamentals of International Regulatory Affairs, Second Edition

Regulatory Affairs Professionals Society (RAPS)

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. 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 EU Regulatory Affairs, Eighth Edition

See the best price to sell, buy, or rent books by Regulatory Affairs Professionals Society (RAPS). BookScouter helps to compare book prices from 25+ online bookstores and 30+ buyback vendors with a single search.

Books by Regulatory Affairs Professionals Society (RAPS)

See the best price to sell, buy, or rent books by Regulatory Affairs Professionals Society (RAPS). BookScouter helps to compare book prices from 25+ online bookstores and 30+ buyback vendors with a single search.

Fundamentals of International Regulatory Affairs, Second Edition

Fundamentals of EU Regulatory Affairs, Eighth Edition