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Fundamentals of US Regulatory Affairs

Pamela Jones

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Description:This 10th edition of Fundamentals of US Regulatory Affairs presents information covering all lifecycle stages of regulated healthcare products. More than 50 authors contributed to the content, which is current through May 2017. New chapters in this edition include preclinical and clinical chapters on drugs and medical devices, biosimilars, and traceability and supply chain. The book is divided into seven sections: I: General Information II: Drugs III: Medical Devices IV: Biologics V: Other Product Classifications VI: Inspection and Enforcement VII: Resources General chapters cover such topics as the history of US regulation, FDA meetings, user fees, regulatory strategy, healthcare fraud and abuse and the new traceability chapter. The product-specific sections track development through postmarket compliance. Other products include topics like orphan drugs, foods, cosmetics, blood products and those derived from blood as well as tissue and cellular products. Who Should Use This Publication? Fundamentals of US Regulatory Affairs is designed for regulatory professionals working in the US market at all levels. Whether you’re new to the profession or a veteran, you’ll find valuable information in the carefully curated pages. Special Offer Get the e-book version when you select the bundled option and save almost 40%. Internet access is required to access RAPS e-books and cannot be dowbloaded. Studying for the RAC? Take a look at our RAC prep resources. Check out RAPS Fundamentals Series. ISBN: 978-0-9977697-7-7 Published by RAPS © 2017. Hardcover. 698 pages.We have made it easy for you to find a PDF Ebooks without any digging. And by having access to our ebooks online or by storing it on your computer, you have convenient answers with Fundamentals of US Regulatory Affairs. To get started finding Fundamentals of US Regulatory Affairs, you are right to find our website which has a comprehensive collection of manuals listed.
Our library is the biggest of these that have literally hundreds of thousands of different products represented.

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Format: PDF, EPUB & Kindle Edition

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ISBN: 0997769777

Description: This 10th edition of Fundamentals of US Regulatory Affairs presents information covering all lifecycle stages of regulated healthcare products. More than 50 authors contributed to the content, which is current through May 2017. New chapters in this edition include preclinical and clinical chapters on drugs and medical devices, biosimilars, and traceability and supply chain. The book is divided into seven sections: I: General Information II: Drugs III: Medical Devices IV: Biologics V: Other Product Classifications VI: Inspection and Enforcement VII: Resources General chapters cover such topics as the history of US regulation, FDA meetings, user fees, regulatory strategy, healthcare fraud and abuse and the new traceability chapter. The product-specific sections track development through postmarket compliance. Other products include topics like orphan drugs, foods, cosmetics, blood products and those derived from blood as well as tissue and cellular products. Who Should Use This Publication? Fundamentals of US Regulatory Affairs is designed for regulatory professionals working in the US market at all levels. Whether you’re new to the profession or a veteran, you’ll find valuable information in the carefully curated pages. Special Offer Get the e-book version when you select the bundled option and save almost 40%. Internet access is required to access RAPS e-books and cannot be dowbloaded. Studying for the RAC? Take a look at our RAC prep resources. Check out RAPS Fundamentals Series. ISBN: 978-0-9977697-7-7 Published by RAPS © 2017. Hardcover. 698 pages.We have made it easy for you to find a PDF Ebooks without any digging. And by having access to our ebooks online or by storing it on your computer, you have convenient answers with Fundamentals of US Regulatory Affairs. To get started finding Fundamentals of US Regulatory Affairs, you are right to find our website which has a comprehensive collection of manuals listed.
Our library is the biggest of these that have literally hundreds of thousands of different products represented.

Special Offer | $0.00

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Fundamentals of US Regulatory Affairs

Fundamentals of US Regulatory Affairs

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