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World Courier - Offering Fully-Integrated GxP-Compliant Global Transport and Storage for the Pharmaceutical Industry White Papers

World Courier - Offering Fully-Integrated GxP-Compliant Global Transport and Storage for the Pharmaceutical Industry

Chinese Regulatory Changes for Human Serum and Plasma Exports Trigger Potential Delays Researchers conducting or planning to conduct clinical trials in China should be aware of new regulatory changes that specifically affect export shipments of human serum and plasma from China and the delays that the new administrative process may create. This free white paper includes a list of these major changes associated with the new regulations.
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Latin America Emerges as World Competitor for Global Trials Despite Tough Regulatory Environment This article examines the regulatory atmosphere that prevails throughout Latin America and considers options that can streamline the timely flow of clinical trial materials through the supply chain.
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Taming China's Clinical Trial 'Dragon' With a population in excess of 1.3 billion and low technical costs, China is a highly attractive venue for clinical trials. In this article, current regulations and permit requirements are examined and a transportation case study is presented. Local solutions and important considerations for choosing appropriate "in country" service providers are also discussed.
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The Urgent Need for Qualified Transportation Providers in Global Clinical Research In light of sobering statistics from the MHRA, WHO and others about the quality of temperature-controlled drugs and medicinal products arriving at global research sites, regulatory agencies and pharmaceutical companies alike are demanding that every party involved in the pharmaceutical supply chain conform to GxP guidelines. This article outlines the main precepts of GxP as it applies to the pharmaceutical transport industry and offers insight on securing the global CTM supply chain.
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