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Sinopsis
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. It is also a valuable study tool for those preparing for the EU RAC exam. New for this edition The fifth edition has been updated to reflect the latest regulatory requirements for medical devices, medicinal products, biologics, blood- and plasma-derived products, cosmetics, food supplements and veterinary products, as well as specialised regulations on orphan products, paediatric products and tissue products.
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