New book from RAPS examines risk management for drugs and medical devices

The Regulatory Affairs Professionals Society (RAPS) has published an authoritative new book covering the theory and application of risk management principles as they relate to the development and approval of drugs and medical devices.

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The 145-page publication, Risk Management Principles for Devices and Pharmaceuticals: Global Perspectives on the Benefit: Risk Assessment of Medicinal Products, features 16 chapters written by 29 regulators, contractors, academics and global industry experts, representing organizations including the US Food and Drug Administration, Eli Lilly and Company, Bayer Pharma, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) and others.

The chapter, Risk Management in the Future: Looking Into the Crystal Ball, written by Tjeerd-Pieter van Staa of MHRA, is available as free preview online, published by RAPS’ flagship publication, Regulatory Focus.

Risk Management Principles for Devices and Pharmaceuticals was co-edited by William K. Sietsema, PhD, director of regulatory affairs and global regulatory leader at Amgen Inc., who also serves as an adjunct professor of pharmaceutical sciences at the University of Cincinnati; and J. Michael Sprafka, MPH, PhD, executive director of general medicine and inflammation at the Center for Observational Research within Amgen.

“Every medical therapy has potential benefits and potential risks,” said Sietsema. “It is critical for all stakeholders to thoroughly understand the risks at each stage, from product development right on through patient treatment. Because of this, risk management has emerged in recent years as a core competency for regulatory professionals working with healthcare products.”

“The book addresses risk management issues from scientific concepts to practical application,” said Sprafka. “The authors provide great insight on preclinical planning, quality risk management, risk: benefit assessment, clinical evaluation reports, risk communication and other important topics. The diverse group of authors offers global perspectives, as well, examining risk management regulations in Australia, Canada, the EU, Japan and the US.”

Risk Management Principles for Devices and Pharmaceuticals: Global Perspectives on the Benefit: Risk Assessment of Medicinal Products is available for purchase online directly from RAPS for $44.95 for RAPS members or $54.95 for nonmembers. It is also available via Amazon.

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