Pharmaceutical supply chain security and integrity

Arete-Zoe: Pharmaceutical Supply Chain Integrity and Security – Part 1
Regulations in the U.S., Europe and Asia, and international standards

The material included in these modules serves many interests by facilitating understanding of construct, dynamics, and influences affecting regulatory policies and corporate decision-making that ultimately determine access, availability, and safety of pharmaceutical products. In the following modules, we will introduce and describe the regulatory environment in the United States, European Union, in major Asian economies such as Japan, India and China, regulatory policies in Russia, and international standards. The video presentations guide students through highly specialized and often disconnected national and supra-nationals regulatory environments that govern pharmaceutical supply chain. Although national variants of Good Distribution Practice guidelines are the key component, they are not the sole focus of this course. Strategic national interests drive national regulatory policies and direct or limit national and international enforcement efforts. Holistic understanding of regulatory environment in global context is essential for understanding of the challenges in pharmaceutical supply chain in the current globalized, inter-connected and inter-dependent economy. See more


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