Thinking Does Not Hurt

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Pharmaceutical Supply Chain Security and Integrity

The course material serves many interests by facilitating understanding of environment, dynamics, and influences affecting regulatory policies and corporate decision-making that ultimately determine access, availability, and safety of pharmaceutical products.  In the first four chapters, 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. Holistic understanding of the regulatory environment in the global context is essential for an understanding of the challenges in pharmaceutical supply chain in the current globalized, interconnected and inter-dependent economy. In chapter “Enforcement”, we will introduce national enforcement systems in the context of globally operating pharmaceutical industry, and present major initiatives and events. Industry trends such as consolidation, outsourcing of key operations, and shift of manufacturing to Asia determine operational environment. Limited sourcing options and increasing complexity and distance affect vulnerability to disruption. Track and trace requirements introduced new vulnerabilities, especially in the information management domain.