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BS973 - Biopharmaceutical Product and Clinical Development

  • Module code: BS973
  • Module name: Biopharmaceutical Product and Clinical Development
  • Department: School of Life Sciences
  • Credit: 10

Content and teaching | Assessment | Availability

Module content and teaching

Principal aims

"This module is designed to equip students with the knowledge and skills base to guide a potential new biopharmaceutical product through the regulatory, product approval and marketing stages of commercialisation. It is a core module for the MSc in Biotechnology, Bioprocessing and Business Management which when combined with other electives in the biopharmaceutical area will provide a new industrial focus for students pursuing this Masters programme. The context of this module is that it sits within a programme that seeks to explain the increasing importance of integrating knowledge transfer, key regulatory and ethical issues, protection of ideas generation and funding to commercialisation. "

Principal learning outcomes

Subject knowledge and understanding: By the end of the module the student should have a broad knowledge and understanding of biopharmaceuticals; development, pre-clinical safety studies, regulatory agencies policies and guidelines; manufacture; chemistry, manufacture and control (CMC); good manufacturing practice and quality assurance; regulation and regulatory authorities. Recognise and analyse the problems associated with the development and use of biopharmaceuticals in a commercial process. Recognise the underlying principles re clinical trials, manufacture and commercial implementation of biopharmaceuticals. The role of a multi-disciplinary approach in the commercialisation of biopharmaceuticals. Be aware of issues involved in the exploitation of a biopharmaceutical process. Demonstrate an understanding of ethical issues pertinent to exploitation and commercialisation of biopharmaceuticals.

Timetabled teaching activities

Lectures per week 10 x 1 hour; Seminar sessions 8 x 1 hour.

Departmental link

Module assessment

Assessment group Assessment name Percentage
10 CATS (Module code: BS973-10)
D2 (Assessed/examined work) 1st Case Study Seminar Presentation 10%
  2nd Case Study Seminar Presentation 10%
  3rd Case Study Seminar Presentation 10%
  4th Case Study Seminar Presentation 10%
  5th Case Study Seminar Presentation 10%
  6th Case Study Seminar Presentation 10%
  MCQ examination (locally held) 40%

Module availability

This module is available on the following courses:

  • Postgraduate Medical Biotechnology and Business Management (J7N2) - Year 1
Optional Core