Product Life Cycle Management BIOL5448

• Academic Session: 2025-26
• School: MVLS College Services
• Credits: 10
• Level: Level 5 (SCQF level 11)
• Typically Offered: Semester 1
• Available to Visiting Students: No

Short Description

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.

Timetable

This course will run in Semester 1.

Excluded Courses

None

Co-requisites

None

Assessment

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)

Course Aims

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.

Intended Learning Outcomes of Course

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.

Minimum Requirement for Award of Credits

Students must submit at least 75% by weight of the components (including examinations) of the course’s summative assessment.