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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.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
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.
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. application.
Who should buy this publication?
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.
Also available as an e-book.
To purchase both the hardcover and e-book versions, add either item to your cart, then select the other format listed under "Optionally select from the following items:" at a discounted rate on the next screen. Discount is only available when purchasing both versions in the same transaction.
Interested in International regulatory affairs but want to concentrate on a particular product sector? RAPS offers the option to purchase the sector-specific content of this book relating to either medical devices or pharmaceuticals individually in e-book format.