Biotechnology is a highly competitive and regulated industry. Understanding the product life-cycle is crucial in ensuring efficient development of high quality and safe products that comply with regulatory standards and achieve market success. This course provides a complete overview of the biotechnology product life cycle, from initial concept, research and development and testing through to market launch and post-launch surveillance.

This course will run in semester 1

None

1. Group presentation of product roadmap for a biotechnology product (10 minutes, 25%) - (ILO 1 & 2)

2. Report individually on a biotech product with quality management plan (1500 words, 75%) - (ILO3) 

This course aims to help students:

■ Build an understanding of the complete life-cycle of a product in the Biotechnology industry;

■ Explore the regulatory frameworks governing biotechnology products;

■ Overview of the principles of quality assurance, Good Manufacturing Processes (GMP) and risk assessment;

■ Develop management and communication skills relevant to a wide range of roles in the biotechnology industry and beyond.

By the end of this course students will be able to:

1. Critically evaluate the key stages of the product life cycle and justify the importance of efficient management;

2. Design a product life cycle roadmap for a biotechnology product;

3. Formulate risk assessment strategies to address potential challenges throughout the product life cycle.