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Full-Text Articles in Pharmacy Administration, Policy and Regulation

“Holistic Risk-Based Site Surveillance – A Data-Based Approach To Site Quality Risk Identification And Assessment In The Pharmaceutical Industry”, Matteo Bernasconi, Thomas Friedli, Nuala Calnan (Editor) Dec 2021

“Holistic Risk-Based Site Surveillance – A Data-Based Approach To Site Quality Risk Identification And Assessment In The Pharmaceutical Industry”, Matteo Bernasconi, Thomas Friedli, Nuala Calnan (Editor)

Level 3

Effective quality risk management is fundamental in guaranteeing the development and manufacture of high-quality drugs, reducing drug shortages, and avoiding harm to patients’ health. The ability to accurately assess the actual risk environment, predict potential product quality or supply disruption issues and act to eliminate, prevent, reduce or mitigate them is key to improvements in quality management maturity. This paper illustrates a just-launched research project aimed at developing a comprehensive framework for how to assess and predict risks by leveraging a range of diverse factors.


An Evaluation Of The Usda's Policy To Reduce Listeria Illnesses In Ready‐To‐Eat Meat And Poultry Products, Travis Minor, Matt Parrett Jan 2020

An Evaluation Of The Usda's Policy To Reduce Listeria Illnesses In Ready‐To‐Eat Meat And Poultry Products, Travis Minor, Matt Parrett

Food and Drug Administration Papers

Using 1998–2008 data collected by the Centers for Disease Control and Prevention on foodborne illnesses and outbreaks, we examine the economic impact of the United States Department of Agriculture's proposed and final rules to reduce the incidence of Listeria monocytogenes (Lm) in ready‐to‐ eat meat and poultry products. Using a difference‐in‐ differences approach, we find that these rules together reduced meat‐related Lm illnesses by about 60 per year, which we attribute to reductions in both the number and average size of meat‐related Lm outbreaks. We then monetize this illness reduction using an underreporting and underdiagnosis multiplier of 2.3 and an …


Moseying Along At The Fda, Rodney Richmond Nov 2016

Moseying Along At The Fda, Rodney Richmond

College of Pharmacy Faculty Research ​and Publications

No abstract provided.


Keeping An Eye On The Fda, Rodney Richmond Aug 2016

Keeping An Eye On The Fda, Rodney Richmond

College of Pharmacy Faculty Research ​and Publications

No abstract provided.


Fda Has A Banner Quarter To Finish Out 2016, Rodney Richmond Feb 2016

Fda Has A Banner Quarter To Finish Out 2016, Rodney Richmond

College of Pharmacy Faculty Research ​and Publications

No abstract provided.


Book Review, Jennifer L. Frizzell Jun 1992

Book Review, Jennifer L. Frizzell

RISK: Health, Safety & Environment (1990-2002)

Review of the following: THOMAS SZASZ, OUR RIGHT TO DRUGS: THE CASE FOR A FREE MARKET. (Praeger 1992) [164 pp.] Notes, bibliography, name index, notes, preface, subject index. LC: 91-30378; ISBN: 0-275-94216-3. [Cloth $19.95. P.O. Box 5007, Westwood CT 06881-9990.]