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
  • Collaborative Online International Learning: No
  • Curriculum For Life: 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

Requirements of Entry

None

Excluded Courses

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) 

Are reassessment opportunities available for all summative assessments? No

Reassessments are normally available for all courses, except those which contribute to the Honours classification. Where, exceptionally, reassessment on Honours courses is required to satisfy professional/accreditation requirements, only the overall course grade achieved at the first attempt will contribute to the Honours classification. For non-Honours courses, students are offered reassessment in all or any of the components of assessment if the satisfactory (threshold) grade for the overall course is not achieved at the first attempt. This is normally grade D3 for undergraduate students and grade C3 for postgraduate students. Exceptionally it may not be possible to offer reassessment of some coursework items, in which case the mark achieved at the first attempt will be counted towards the final course grade. Any such exceptions for this course are described below. 

 

Group-work is not re-assesasble.

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.