Driving a product to the market safely, quickly, and cheaply is the best way for a pharmaceutical (Pharma) firm to be successful. Pharmaceutical companies encounter enormous challenges during the long product-development process. Today's fast-paced competition requires efficiency in all aspects of the business. Identifying risks at the right stage and an effective mitigation plan are key factors for success, both financially and technically.
The complex drug-development process from lab to launch includes managing several business processes, such as technical development using quality by design, regulatory strategy, clinical studies, and supply chain. These processes are affected not only by many circumstantial factors but also by each other. The inherent uncertainties during the evolution of any of these processes require a constant change in plans.
If the risks associated with the uncertainties are not managed in a timely and effective manner, the complexity of the situation increases dramatically, and it subsequently becomes cost-prohibitive for the developing industries to move forward. Although project management has been known to drive industrial success through effective risk management in other industries, it has only been introduced to the Pharma industry in the last decade and is continuously evolving.
This 6-week MBA-PIM Module identifies challenges in project management in the Pharma industry. The analysis of critical factors, such as project managers and stakeholders' roles, team communication, and key business processes, helps to identify strategies for addressing these challenges. This process can help put Pharma companies on the road to success in launching a quality product that can improve quality of life.
Project management becomes more complex due to known risks (known-unknown) and unknown risks (unknown-unknown). Lack of effective risk management can result in turbulence (chaos) in the project that can be uncontrollable. The use of available techniques, such as Program Evaluation and Review Technique (PERT) and Gantt charts, helps identify risks and develop amitigation and contingency plan, which is beneficial in managing the known or foreseeable risks.
The Core Topics covered in this module include:
• Scope management
• Project planning, execution, and monitoring Timeline and budget planning and management Stakeholder management
• Management of regulatory and compliance strategies Environmental safety
• Risk management
• Team management