Project Management in pharmaceutical industry
Abstract
Project management is a discipline that can be applied to all industries, regardless of the product or service they are designed to deliver. Beyond its basic application across various industries, project management has tremendous value when effectively implemented to significantly increase the success of the product or service being delivered.
In the pharmaceutical industry, project management plays a big role in managing such a complex context due to unique regulatory, compliance and quality related needs of the industry. Pharmaceutical companies are now facing a new phase in which there are enormous challenges in the long product-development process. Delivering a new product to the market safely, quickly and cheaply is the best way for them to be successful. But an increasing competition, more stringent regulatory requirements and increasing costs for R&D are giving pharmaceutical firms even more challenges and the need to restructure their strategies trying to be more agile, and reduce the internal costs. Efficiency in all the aspect of business are thus fundamental. In general, it takes 10 to 15 years to launch a new product in the market. The activities related to the launch require coordination between many different stakeholders both internally as R&D, regulatory, legal, finance, supply chain, sales, and marketing, and externally with partners . It is therefore really important to get these activities coordinated in an efficient way. During this period of uncertainty a lot of things can happen and this makes the planning part of the project more difficult. The company then has to take decision and adjust the plans along the process. It is considerably important to evaluate all the threats, and the risks must be treated in an effective and timely manner. The complexity would otherwise increase and the project becomes cost prohibitive. Although all these activities of coordination are required, project management has only been introduced to the pharmaceutical industry in the last two decades and is continuously evolving.
This article defines and identifies challenges in project management in pharmaceutical industry, describing the critical factors and the key roles, and helps to identify ways of dealing with these challenges.
