THE UNIVERSITY of EDINBURGH

DEGREE REGULATIONS & PROGRAMMES OF STUDY 2016/2017

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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 Issues 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 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; particularly in health and agricultural sectors.

Outline Content

1. Health Regulation, Governance and the Challenge of Advanced Therapies

This session investigates some of the challenges of designing and conducting clinical trials for novel therapies, and explores the relationship between developers of new drugs and the regulatory institutions that govern them.

2. Managing Risk and Uncertainty for Genetically Modified Organisms (GMOs) and Impact on the Agro-Biotechnology Industry

This session explores the regulation of GMOs, particularly in Europe, and reveals the challenges of managing risk and uncertainty in the context of a highly divisive and political issue that reveals a growing risk-assessment policy gap.

3. Intellectual Property, Patenting and Governance

This session will cover the different forms of intellectual property (IP) with a special emphasis on patenting. Students will be introduced to what a patent looks like and its requirements. The institutions that make up the IP framework will be discussed, including national and regional patent offices and laws, the WTO and The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

4. The Role of Stakeholders in the Governance of Life Science Innovation: Social and Ethical Issues

This session explores some of the current and emerging social, ethical and political issues that pose a challenge to those responsible for the regulation and governance of life science research. In particular, we will explore issues around informed consent, protection of confidentiality, access, and research participation/recruitment in the context of patient specific biological material and genomic data.

5. Student Led Workshop/Presentations

This session will involve student-led, group presentations and discussion. Small groups of 3-4 students will take a real or imagined agricultural or therapeutic technology or product and think through how to take it to market in the context of regulatory and governance challenges.

The course, which has no prerequisites, is delivered through a 5-week lecture and seminar discussion format. The two-hour sessions will typically consist of a short lecture (introducing the key themes of the week's topic and the core readings provided), followed by an hour and a quarter of classroom discussion and/