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The highly-anticipated fifth edition is here! Get the must-have resource for achieving compliance with medical device regulations.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
RAPS Fundamentals of Regulatory Affairs Series provides the foundational knowledge needed to keep abreast of global regulations for pharmaceuticals, medical devices, biologics, and other healthcare products. This series constitutes the most extensive collection of resources available on global regulatory affairs and is essential for anyone who needs to know and understand regulations and legislation from various regions of the world, including the US, Europe, Canada, and Japan.
RAPS medical devices collection will benefit individuals working in multinational medical device and in vitro diagnostic (IVD) 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. Gain access to global regulations for devices and in vitro diagnostic devices, from premarket through postmarket and represent the state of the art in regulatory sciences.
Our pharmaceutical-related books span the entire lifecycle for medicinal products from clinical trial application to dossier preparation and on through postmarketing activities and requirements. These outstanding resources will benefit individuals working in multinational pharmaceutical and biologics product development and marketing at all levels.
RAPS’ broad collection of biotechnology resources offers the latest on global regulations and legislation governing products derived from biotechnology, including biosimilars, vaccines, and biologics. Topics include product labeling, promotion, REMS, regulatory intelligence, and more.
RAPS has curated a collection of business and career development tools that will enhance your skills, improve financial performance and leadership development, and sharpen your writing, communication, and negotiation skills.