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Risk Management: What Regulatory Professionals Need to Know

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By Zachary Brousseau, RAPS senior manager, communications

RAPS’ latest publication covers the theory and application of risk management principles as they relate to the development and approval of drugs and medical devices. 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.

Risk Management Principles book

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.

Regulatory Focus caught up with Sietsema for his perspective on risk management principles and how the book addresses them. Following is an edited transcript.

Regulatory Focus: What core risk management concepts should all regulatory professionals know? Why are they important?

William Sietsema: Core risk management concepts include how to identify potential risks, how to develop a system for continued assessment of risks, and how to develop a plan for risk mitigation, including pre-defined action points. These are important to protect the public health and maintain confidence in a product.

RF: Are risk management principles applied differently to medicinal products than other areas where one might need to balance benefit and risk?

WS: Risk management principles are similar in the pharmaceutical and medical device industries to what is observed in other industries, but the types of risks, methods of detection and methods of mitigation may be much different than in other industries.

RF: The book, Risk Management Principles for Devices and Pharmaceuticals, examines risk as applied in several different national or regional regulatory systems, including the US, EU, Canada and Japan. How is risk handled differently by different regulators? What are the common threads?

WS: Due to the International Conference on Harmonisation (ICH), there are more commonalities than differences in each of these regions. Most of the differences between regions are procedural in nature. All regions expect good science to form the foundation for risk management.

RF: Who is likely to benefit most from reading this book?

WS: Anyone with a role in regulatory affairs or safety would benefit from the excellent insights this book offers from world renowned authors and experts.

RF: What does the future hold for risk management?

WS: Risk management is a relatively young discipline and is evolving rapidly. Our ability to detect and mitigate risks will improve as new tools and algorithms are made available, and as the industry gains more experience identifying the methods of mitigation that work well and those that don’t.

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. The chapter, Risk Management in the Future: Looking Into the Crystal Ball, written by Tjeerd-Pieter van Staa of MHRA, has been published by Regulatory Focus as free preview.




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