11.06.12 -- The Global Pharmacovigilance Landscape: Beyond The U.S. And EU

2021-12-30 06:55:01 By : Ms. Julia Zhang

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The Global Pharmacovigilance Landscape: Beyond The U.S. And EU By Norwich Clinical Services The World Health Organization describes pharmacovigilance as the process of detecting, assessing, understanding, and preventing adverse events associated with medicinal products, with the aim of enhancing patient care and safety. While the goal of pharmacovigilance remains constant, the methods, resources, and regulations that are designed to reach this goal are continuously being updated and optimized.

Preventing Cross Contamination Of Potent Compounds By Paul Doherty, Ferro Pfanstiehl Laboratories This article will touch on the philosophy and methods used to prevent cross contamination of a potent compound into other products produced at a multiple product facility. The key to preventing cross contamination of potent compounds into other products is to establish a site policy and system that establishes the administrative and engineering standards, controls, and practices for containment of potent compounds.

Pharmaceutical Manufacturers Look To Workforce Management Software To Counter Industry Challenges By Eric Newmark, Program Director, Life Science Business Systems Strategies Pharmaceutical manufacturers continue to endure considerable top-line and bottom-line pressure as the industry grapples with widespread patent expirations, shrinking product pipelines, increasing generic competition, growing regulatory oversight, rising compliance costs, and an uncertain economy.

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Security And Temperature Control In The Cold Chain With the increase in global pharmaceutical shipments, driven by the aging of the world’s population and the increase in available therapies, many pharmaceutical and biotech executives are hindered in their attempts to provide an accurate cost benefit analysis of the transport of their drugs to market.

The Urgent Need For Qualified Transportation Providers In Global Clinical Research Given the high cost of conducting global clinical trials, and the even higher cost of failure, regulatory agencies and pharmaceutical companies alike now demand that every party involved in the pharmaceutical supply chain — transportation and logistics providers included — conform to GxP guidelines.

Evolving From Cold Chain Logistics Management To Cold Chain Logistics Control Particularly for companies involved in the life sciences, the entire field of cold chain logistics has undergone significant changes in relatively few years.

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