Organization of Counterfeit Protection Management Holistic Approach Dr. Stephan Schwarze Bayer Schering Pharma AG, Berlin (Germany) A conceptual model encompassing the area of knowledge, prevention, reaction, monitoring and continuous learning process forms the basis for the implementation of organization and processes to assure adequate counterfeit protection in the pharmaceutical industry. This holistic approach as part of risk management is seen to be mandatory to appropriately respond to the fast-growing challenge of counterfeited pharmaceutical drug products. The most important aspects to be covered in the distinct areas of activity are explained in detail as for instance factors influencing decisions with respect to the holistic approach, market model of supply and demand, a three-level model to safeguard products, reaction capabilities making the difference or monitoring needs. |
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pharmind 2009, Nr. 5, Seite 799