PROJECT MANAGEMENT IN PHARMACEUTICAL INDUSTRY

Abstract

Driving a product to the market safely, quickly, and cheaply is the best way for a pharmaceutical company to be successful. In the era of an increased consumer demand for pharmaceutical products, the complex process of new product development has to be shortened as much as possible without damaging the overall quality and efficacy of the new product. The pharmaceutical industry is booming, and the race in delivering new products to the market is speeding up. Pharmaceutical companies encounter enormous challenges during the long and extremely complex product-development process. From the initial research in the early laboratory stages until the ultimate product market launch, this long process includes management in a number of different business processes, such as technical development using quality by design, regulatory strategy, clinical studies, and supply chain. To be able to find the most cost-effective ways of speeding up the process of development of new products, and particularly of the clinical trial phase, pharmaceutical companies faced up the need of introducing and implementing project management, which in other manufacturing industries was done a long time ago. Identification of risks of each of the phases in the process and an effective risk mitigation plan became key factors for success for these companies, both from financial and technical perspective. However, implementation of effective project management in launching new products does not only support the success and profitability of pharmaceutical companies. Effective project management in the pharmaceutical industry also makes available new medical discoveries for patients in need sooner and at lower costs, and by enabling a treatment for a certain disease supports maintenance of human health and improves the quality of life worldwide. The article begins with introduction, continues with the interconnection between the new product development and the need of implementing project management in the pharmaceutical industry, refers to the planning of clinical trials of new products as a very important phase of the business life cycle in this industry, explains the basic definition of project management in the pharmaceutical industry and its specifics, and ends with a conclusion