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DRPS : Course Catalogue : School of Social and Political Science : Postgrad (School of Social and Political Studies)

Postgraduate Course: Regulation and Governance of the Life Sciences (PGSP11396)

Course Outline
SchoolSchool of Social and Political Science CollegeCollege of Humanities and Social Science
Credit level (Normal year taken)SCQF Level 11 (Postgraduate) AvailabilityAvailable to all students
SCQF Credits10 ECTS Credits5
SummaryIssues of risk, governance and regulation have had a particular resonance in a range of life science sectors. Indeed, processes of regulation and risk management are a core component of most life science industries and shape the very nature of innovation. It is essential for students wanting training in core competencies and broader knowledge and understanding of the bioeconomy to be acquainted with systemic issues around risk governance and regulation as they apply to different sectors within the life sciences. This Course is an essential component of the BIG Programme and provides in-depth knowledge and understanding, through rich case studies from the contributors┐ long-standing expertise and research findings in the field, of how regulation and risk-governance processes have impacted on life science-based innovations in the health, agriculture and environmental sectors.
Course description WEEK TOPIC
1 Health Regulation and the Clinical Trial System
2 Regulatory Challenges for Advanced Therapies: The Need for 'Smart Regulation'?
3 Regulation of GMOs and Impact on the Agro-Biotechnology Industry
4 Role of Patients and other Stakeholders in Governance of Health Innovation: Social and Ethical Issues
5 Legal Challenges of Commercialisation and Governance of Biological Material

The majority of the students for this course will be those from the new BIG MSc programme, but it will also be offered to other programmes within STIS, the GPHU as well as being offered to those students on the doctoral training programme. It will have particular appeal to those students throughout the school with an interest in the life science sectors and wanting greater knowledge and understanding of risk, regulation and governance. This course will also be an attractive option to students on Programmes throughout the School of Social and Political Science where there is an interest in innovation and strategic decision-making including the MSc in Science and Technology Studies, the MSc in African Studies and the MSc in Carbon Management offered by the School of GeoSciences and the Business School.
Entry Requirements (not applicable to Visiting Students)
Pre-requisites Co-requisites
Prohibited Combinations Other requirements None
Information for Visiting Students
High Demand Course? Yes
Course Delivery Information
Academic year 2015/16, Available to all students (SV1) Quota:  30
Course Start Block 2 (Sem 1)
Timetable Timetable
Learning and Teaching activities (Further Info) Total Hours: 100 ( Lecture Hours 10, Programme Level Learning and Teaching Hours 2, Directed Learning and Independent Learning Hours 88 )
Assessment (Further Info) Written Exam 0 %, Coursework 100 %, Practical Exam 0 %
Additional Information (Assessment) Assessment will be a final essay of 3000 words on a topic to be agreed between the student and the course convener. This might be a conventional research paper, literature review, or the application of a risk governance process for a new or existing life science technology or product. The assessment might also be an exercise in foresight or scenario planning in a specific area of the bioeconomy.
Feedback Not entered
No Exam Information
Learning Outcomes
On completion of this course, the student will be able to:
  1. Have a clear understanding, based in key theories and concepts, of how risk governance and regulatory regimes function in different sectors of the bioeconomy, and be able to critically evaluate the potential of different risk-benefit models for product and process innovations.
  2. Be able to analyse and appraise the systemic role of regulation in both early and late stage R&D, and be able to think critically about the broader governance of life science innovation and role different stakeholders can play in risk management.
  3. Have developed specific knowledge and understanding of the different methods for studying risk governance and regulation, as well as key skills in foresight/scenario planning to identify known and potential risks and develop strategies to mitigate them within different sectors of the bioeconomy.
  4. Appreciate the distinctiveness of regulatory and governance processes in the life sciences as opposed to those within other industries, such as Information and Communication Technologies (ICT).
Reading List
Brevignon-Dodin, L. (2010) Regulatory Enablers and Regulatory Challenges for the Development of Tissue-Engineered Products in the EU, Bio-Medical Materials and Engineering (in press) DOI 10.3233/BME-2010-0623
Eriksson, L. and A. Webster (2008) Standardising the Unknown: Practical Pluripotency as Doable Futures, Science as Culture, 17 (1), pp. 57-69
Kuiper HA, Davies HV (2010) The SAFE FOODS risk analysis framework suitable for GMOs? A case study. Food Control 21: 1662-1676
Lovell-Badge, R. (2008) The Regulation of Human Embryo and Stem-Cell Research in the United Kingdom, Nat Rev Moll Cell Biol 9 (12), pp. 998-1003
Lyall C, Tait J (2005) New Modes of Governance: Developing an Integrated Policy Approach to Science, Technology, Risk and the Environment. Aldershot, UK: Ashgate
May, C.R. and N.T. Ellis (2001) When Protocols Fail: Technical Evaluation, Biomedical Knowledge, and the Social Production of Facts about a Telemedicine Clinic, Social Science and Medicine, 53, pp. 989-1002
Mittra, J. (2006) Genetic Exceptionalism and Precautionary Politics: Regulating for Uncertainty in Britain's Genetics and Insurance Policy Process', Science and Public Policy, 33 (8) pp. 585-600
Mittra, J., & Tait, J. (2009) Stem Cells, chapter for RiskBridge Report , SAS6-CT-2006-036661, pp. 224-268
Mittra, J. (2009) Riskbridge Conference Proceedings, Brussels, 26-27 March 2009
Parthasarathy, S (2004), Regulating Risk: Defining Genetic Privacy in the United States and Britain, Science, Technology and Human Values, 29 (3), pages 332-352.
Tait, J. (2007) Systemic Interactions in Life Science Innovation┐, Technology Analysis and Strategic Management, 19 (2), pp. 257-277

Further reading material is provided in the course handbook uploaded to Learn.
Tait, J. And J. Chataway (2007) 'The Governance of Corporations, Technological Change and Risk: Examining Industrial Perspectives on the Development of Genetically Modified Crops' Environment and Planning C: Government and Policy, 25, pp. 21-37.
Tait, J. & R. Williams (1999) Policy Approaches to Research and Development: Foresight, Framework and Competitiveness, Science and Public Policy, 26 (2), pp. 101-112
Tait, J. & G. Barker (2011) Global Food Security and the Governance of Modern Biotechnologies, EMBO Reports 12, pp. 763-768
Additional Information
Graduate Attributes and Skills Not entered
KeywordsNot entered
Course organiserDr James Mittra
Tel: (0131 6)50 2453
Course secretaryMiss Kate Ferguson
Tel: (0131 6)51 5122
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