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Fundamentals of Regulatory Affairs

Fundamentals of Regulatory Affairs books are recognized and trusted as the essential reference guides for regulatory professionals. Developed by established regulatory experts, each Fundamentals book provides a comprehensive understanding of the most current regulatory requirements across product lines. They lay out complex regulatory information clearly and concisely, with easy-to-read charts and analysis.

The publications are used by more than a dozen universities as a required text, some of the largest healthcare organizations as a staple in each employee’s office and RAC Exam takers as a key study tool.

Fundamentals of Canadian Regulatory Affairs, Third
Fundamentals of Canadian Regulatory Affairs, Third Edition
Available
A comprehensive reference text that includes essential information for regulatory professionals working with healthcare products for the Canadian market

List Price: $299.95
Member Price: $239.95
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Fundamentals of Japanese Regulatory Affairs
Fundamentals of Japanese Regulatory Affairs, First Edition
Available
This English edition is an indispensible resource for regulatory professionals working on products for the Japanese market.

List Price: $299.95
Member Price: $239.95
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Fundamentals of International Regulatory Affairs
Fundamentals of International Regulatory Affairs, First Edition
Available
This highly acclaimed publication is the perfect reference tool for any regulatory affairs professional working internationally.

List Price: $259.95
Member Price: $199.95
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Fundamentals of EU Regulatory Affairs, Fifth Editi
Fundamentals of EU Regulatory Affairs, Fifth Edition
Available
This book is an indispensable resource for professionals at all levels providing a comprehensive examination of applicable directives, regulations and national laws across the lifecycle for all product lines in the EU.

List Price: $299.95
Member Price: $239.95
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Global Medical Device Regulations
Global Medical Device Regulations
Available
A compilation of chapters covering medical device regulation, adapted from the five books in RAPS’ Fundamentals of Regulatory Affairs series.

List Price: $299.95
Member Price: $239.95
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Fundamentals of US Regulatory Affairs, Seventh Edi
Fundamentals of US Regulatory Affairs, Seventh Edition
Available
This highly acclaimed publication is the perfect reference tool for any US regulatory affairs professional.

List Price: $299.95
Member Price: $239.95
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