The assignment requires 15 substantive content slides, which do not include titl

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The assignment requires 15 substantive content slides, which do not include titles and transition slides, to include: an introduction to your topic, why it is important, highlighted problems/complications, suggested solutions and a conclusion. MY TOPIC: The topic I picked was “Intellectual Property Rights Protection in Regulatory Affairs”. Among regulated industries such as the pharmaceutical industry, intellectual property (IP) rights are of the utmost importance. Protecting intellectual property benefits both manufacturers and consumers. In developing new products, IP rights play a critical role in showing that an individual or entity has the right to a specific creation. These rights offer creators the protection of their ideas and inventions so that they may ultimately benefit from their inventions (Reichman, 2009). Indeed, IP rights promote innovation in various industries by allowing companies and individuals to pay particular attention and focus and invest resources in research and development without fear that other entities will steal their ideas and benefit from them. For example, in drug or medical device patents, only the firm holding the patent is permitted to manufacture the specific drug or medical device. IP rights are also essential in regulatory affairs. Certainly, when companies are assured that their product will eventually make a profit before others start making generic products, the inventors can then use their time and resources to make safe, high-quality, and worthwhile products for their consumers (Reichman, 2009). Also, documentation that guarantees IP rights for specific products, such as patents, often contains a detailed description of how the product was made, operates, and ways it should be used. This allows regulatory agencies to understand how an invention such as a new drug complies with relevant regulations for product approval (Eisenberg, 2012). Therefore, while protecting IP rights rewards innovators for their creativity, it also protects consumers by ensuring that they are aware of the reliability, safety, and efficacy of the product they purchase. References Eisenberg, R.S. (2012). Patents and regulatory exclusivity. In P.M. Danzon & S. Nicholson (eds) The oxford handbook of the economics of the biopharmaceutical industry. Oxford University Press. Reichman, J. H. (2009). Rethinking the role of clinical trial data in international intellectual property law: the case for a public goods approach. Marquette Intellectual Property Law Review, 13(1), 1-68.

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