Drug Safety Evaluation and Pharmacovigilance Assignment

Drug Safety Evaluation and Pharmacovigilance - Assignment Example The systems that are used to assess post-marketing events include medical record databases or computerized claims, reports and pre marketing studies. Drug toxicity is frequently a major safety issue for an investigational new drug. This may occur as an unexpected reaction to a nontoxic drug or it may be an expected consequence of the intrinsic toxicity of a drug, taken in a sufficiently large dose (Berlin, 2008). It is the function of pharmaceutical research companies to take the path from understanding a disease to bringing a safe and effective treatment to patients. To ensure that collection of data is complete and to protect the safety of study participants, various processes are put in place during clinical trials (Meadows, 2006). The completeness of data is important in developing an understanding of the advantages and side effects of a new medicine (Meadows, 2006). With one or more solutions at hand, researchers turn their attention to testing them extensively to determine if they should move on to testing in humans. Efficacy and safety of investigational new drugs have an inherent deficiency in the inability to detect major, rare and adverse effects (Talbot, 2011). The limitations of these safety data for predicting post authorization safety profiles must be a consideration. These pre-marketing clinical trial limitations include lack of globally accepted gold standards for determining whether a signal on drug safety represents true risk. While the regulatory bodies have well established regulatory statutes, standards of ascertaining safety are heterogeneous (Edwards & Tilson, 2005). There is limited statistical power in determining the specific harm due to lack of statistical significance in the selected population. The selected patient group is small and excludes patients who are at a greater risk. There is limited generalizability since the study participants are carefully selected. There is a strict criterion of selecting whom to include

The Art of Business in the 21st Century Essay Example | Topics and Well Written Essays - 1250 words

The Art of Business in the 21st Century - Essay Example Recognizing the value of information to the 21st century business, the paper recommends the use of ERP software for business. Every enterprise strives to be profitable and dominant in its industry, but it is only those firms that continually strive to understand their areas of operation through application of industry research and innovation that eventually register significant success. Michael Porter a professor at the Harvard Business School suggests a model that can enable business to understand the key drivers or factors, which can contribute to business success and competitive advantage. Porter’s value-chain model represents a framework that can enable a business analyze specific activities, which will create value and guarantee competitive advantage. First and foremost, the business has to analyze its inbound logistics and processes that include the processes of receiving goods and raw materials, storage and inventory control as well as transportation scheduling. The bus iness must aim at bringing efficiency and effectiveness by changing and improving inbound logistic processes. It therefore calls for innovation and creativity on the part of everybody within the organization. Inbound logistics represent one side of the coin, outbound logistics, which entails all the activities necessary to get the completed product to the clients, such as warehousing, order fulfillment, transportation and distribution management, must also be looked into. Streamlining inbound and outbound processes will guarantee efficiency. Another area that the business must seek to improve on a continually basis is its operations. This includes machining, packaging, assembly, equipment maintenance, testing and any other value-creating activities that seek to transform the inputs into the finished product (Porter 3). Customers need to be aware of the existing products that the firm produces. Therefore, marketing and sales department is an indispensable part any business that wants to be profitable. Sales and marketing entails all activities related with getting buyers to buy the product including pricing, channel selection, retail management advertising, selling and promotion. The business must also look into its service delivery. Service delivery involves all activities that aim at enhancing and maintaining a product's value. This also includes customer support, repair services, management of spare parts and upgrading. In addition to service delivery, the enterprise must streamline its procurement processes. These processes include the procurement of raw materials, servicing, spare parts, buildings and machines. A successful business also takes advantage of technology. Therefore, the business must be able to budget for technology development to support the value chain activities. Technology development initiatives may include research and development, process, automation as well as design and redesign. Lastly, the general management, legal, planning managem ent, finance, accounting, quality management, public affairs, which form the firm's infrastructure must be aligned in a way so as to provide for efficient business operation. Porter also continues to argue that a business is usually affected by a number of forces that will either act positively to ensure business success or if