<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 lines Featuring: * International guidance documents from ICH, GHTF, WHO and ISO * Comparison of submission requirements around the world * Illustrative figures and tables</p>

Fundamentals of International Regulatory Affairs, First Edition

Regulatory Affairs Professionals Society

Regulatory Affairs Professiona

<p>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.</p>

Fundamentals of US Regulatory Affairs Hardcover

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

Books by Regulatory Affairs Professiona

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

Fundamentals of International Regulatory Affairs, First Edition

Fundamentals of US Regulatory Affairs Hardcover