Implementing a globally harmonized risk assessment‐based approach for regulatory decision‐making of crop protection products

2020 ◽  
Vol 76 (10) ◽  
pp. 3311-3315 ◽  
Author(s):  
Douglas C Wolf ◽  
Manoj Aggarwal ◽  
Michael Battalora ◽  
Ann Blacker ◽  
Shadia I Catalano ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Decision Making ◽  
Crop Protection ◽  
Regulatory Decision

The Extension of Molecular and Computational Information to Risk Assessment and Regulatory Decision Making*

2006 ◽  
pp. 151-180 ◽  
Author(s):  
James Bus ◽  
Richard Canady ◽  
Tracy Collier ◽  
J William Owens ◽  
Syril Pettit ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Decision Making ◽  
Regulatory Decision

The use of risk assessment in regulatory decision making: Time for a review

1981 ◽  
Vol 1 (3) ◽  
pp. 264-276 ◽  
Author(s):  
John T. Barr ◽  
Donald H. Hughes ◽  
Robert C. Barnard
Keyword(s):  
Risk Assessment ◽  
Decision Making ◽  
Regulatory Decision

Initiating and Managing Risk Assessments within a Risk Analysis Framework: FDA/CFSAN'S Practical Approach

2004 ◽  
Vol 67 (9) ◽  
pp. 2058-2062 ◽  
Author(s):  
ROBERT L. BUCHANAN ◽  
SHERRI DENNIS ◽  
MARIANNE MILIOTIS
Keyword(s):  
Risk Assessment ◽  
Decision Making ◽  
Risk Management ◽  
Risk Analysis ◽  
Risk Assessments ◽  
Analysis Framework ◽  
Regulatory Decision ◽  
Managing Risk ◽  
Risk Managers ◽  
The U.S

Management of risk analysis involves the integration and coordination of activities associated with risk assessment, risk management, and risk communication. Risk analysis is used to guide regulatory decision making, including trade decisions at national and international levels. The U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition (CFSAN) formed a working group to evaluate and improve the quality and consistency of major risk assessments conducted by the Center. Drawing on risk analysis experiences, CFSAN developed a practical framework for initiating and managing risk assessments, including addressing issues related to (i) commissioning a risk assessment, (ii) interactions between risk managers and risk assessors, and (iii) peer review.

Risk assessment and regulatory decision making

1981 ◽  
Vol 19 ◽  
pp. 549-560 ◽  
Author(s):  
I.C. Munro ◽  
D.R. Krewski
Keyword(s):  
Risk Assessment ◽  
Decision Making ◽  
Regulatory Decision

Drug Safety, Pharmacoepidemiology, and Regulatory Decision Making

1988 ◽  
Vol 22 (4) ◽  
pp. 336-344 ◽  
Author(s):  
Robert C. Nelson
Keyword(s):  
Risk Assessment ◽  
Decision Making ◽  
Conceptual Framework ◽  
Knowledge Base ◽  
Case Studies ◽  
Drug Safety ◽  
Research Question ◽  
Regulatory Decision ◽  
Risk Manager ◽  
Interpretive Framework

The safety or risk assessment of a pharmacotherapeutic agent begins early in its development and continues throughout its use cycle. The practice of pharmacoepidemiology is the art of using the sciences and the tools of science to generate information about pharmaceutical outcomes, including associated risks, in the postmarketing environment. A pharmacoepidemiologist must be capable of functioning with a matrix constructed of three components: a knowledge base, a conceptual framework, and an interpretive framework. From this perspective one can establish surveillance schemes, or understand a posed research question, select strategies, apply methodologies, and interpret the results of purposeful investigations. When conveyed to the risk manager, appropriately interpreted results of a properly conducted risk assessment can be used in regulatory decision making. Seven case studies are presented as examples of this approach.

scholarly journals Evolving Acceptance and Use of RWE for Regulatory Decision Making on the Benefit/Risk Assessment of a Drug in Japan

2021 ◽  
Author(s):  
Kinue Nishioka ◽  
Tomomi Makimura ◽  
Akihiro Ishiguro ◽  
Takahiro Nonaka ◽  
Mitsune Yamaguchi ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Decision Making ◽  
Regulatory Decision ◽  
Benefit Risk Assessment

Risk Assessment and Risk Management of Noncriteria Pollutants

1990 ◽  
Vol 6 (5) ◽  
pp. 245-255 ◽  
Author(s):  
Si Duk Lee
Keyword(s):  
United States ◽  
Risk Assessment ◽  
Decision Making ◽  
Risk Management ◽  
Air Pollutants ◽  
The United States ◽  
Risk Information ◽  
Air Toxics ◽  
Hazardous Air Pollutants ◽  
Regulatory Decision

Noncriteria air pollutants are synonymous with hazardous air pollutants (HAPs), air toxics or toxic air pollutants (TAPs). The term noncriteria pollutants refers to all air pollutants except for the criteria pollutants (SOx, PM, NOx, CO, O3, and Pb). Air toxics are pervasive in our environment worldwide in varying degrees. Uses of these chemicals are varied and numerous; their emissions are ubiquitous, and they include organic compounds such as chlorinated hydrocarbons, dioxins, aldehydes, polynuclear aromatic hydrocarbons, and heavy metals such as chromium, nickel, cadmium, and mercury. There are more than 70,000 chemicals that are in use commercially in the United States, and we know relatively little about their ambient concentrations, persistence, transport and transformation as well as their effects on health and the environment, many of which take decades to emerge. The United States Environmental Protection Agency, under the authority of Section 112 of the Clean Air Act, is mandated to regulate any air pollutant which, in the Administrator's judgment, “causes, or contributes to, air pollution which may reasonably be anticipated to result in an increase in serious irreversible or incapacitating reversible illness.” For such regulatory decision-making, EPA's Office of Health and Environmental Assessment (OHEA) provides scientific assessment of health effects for potentially hazardous air pollutants. In accordance with risk assessment guidelines developed by OHEA over the years, Health Assessment Documents (HADs) containing risk assessment information were prepared and were subjected to critical review and careful revision to produce Final Draft HADs which serve as scientific databases for regulatory decision-making by the Office of Air Quality Planning and Standards (OAQPS) in its risk management process. EPA developed databases such as the Integrated Risk Information System (IRIS) and the National Air Toxics Information Clearinghouse (NATICH) and a technical assistance response system called the Air Risk Information Support Center (AIR RISC), in addition, to help in implementation of the National Air Toxics Program by state and local regulators.

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