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DRPS : Course Catalogue : School of Law : Law

Postgraduate Course: Governance of Innovative Medicine (LAWS11388)

Course Outline
SchoolSchool of Law CollegeCollege of Arts, Humanities and Social Sciences
Credit level (Normal year taken)SCQF Level 11 (Postgraduate)
Course typeOnline Distance Learning AvailabilityNot available to visiting students
SCQF Credits20 ECTS Credits10
SummaryThis is a course about facilitation of the development of innovative medicinal products and their release into the market and clinic, in order to fulfil the societal goal to deliver 'public goods of health'. It provides a framework for thinking about how governance mechanisms enable both the creation of novel research tools and therapeutic products, and their accessibility to the widest community of researchers and patients, in order to ensure their best use to generate the social benefits of health. To do this, the course draws on the notion that innovative medicines have led to innovative governance mechanisms, in a relationship based on dialogue.
Course description The course will give students a fundamental understanding of:

1. The range of actors and activities instrumental to the delivery of health benefits;
2. The types of novel biotechnologies that are shaping research and new models of healthcare;
3. International and EU institutions and instruments establishing human rights and economic regimes conducive to the promotion of human welfare;
4. The relationship between EU risk-based regulation of medicinal products, devices, and ATMPs, and 'facilitative governance' through informal collective and public-private arrangements for the promotion of innovation and its products;
5. The interplay between public and private interests, and their influences on innovative medicine and its governance.

1. Biomedicine - Old & New
2. Global Architecture
3. The European Context
4. Medicines, Devices & Therapies
5. Trials & Tribulations
6. From Regulation to Facilitation
7. Persons & Public Interest
8. Property & Procurement
9. Patents & 'Freedom to Operate'
10. Data Access & Privacy
Entry Requirements (not applicable to Visiting Students)
Pre-requisites Co-requisites
Prohibited Combinations Other requirements Please contact the online learning team at
Additional Costs Students must have regular and reliable access to the internet.
Course Delivery Information
Academic year 2019/20, Not available to visiting students (SS1) Quota:  None
Course Start Semester 1
Timetable Timetable
Learning and Teaching activities (Further Info) Total Hours: 200 ( Seminar/Tutorial Hours 40, Programme Level Learning and Teaching Hours 4, Directed Learning and Independent Learning Hours 156 )
Assessment (Further Info) Written Exam 0 %, Coursework 100 %, Practical Exam 0 %
Additional Information (Assessment) One essay of up to 4,000 words (60%); one written policy development exercise of up to 1,000 words (40%).

Requirements for all course assessments will be outlined to students within the individual courses at the start of each semester.
Feedback Students will have the opportunity to obtain formative feedback over the course of the semester. The feedback provided will assist students in their preparation for the summative assessment.

Details of the School's feedback policy will be available at the start of the course.
No Exam Information
Learning Outcomes
On completion of this course, the student will be able to:
  1. Appreciate the range of competing actors, interests and values at play, and the inherent tensions they create, in the governance of innovative medicine
  2. Demonstrate knowledge that integrates most of the main areas of the subject of regulation and governance of innovative medicine, including a critical awareness and understanding of the challenges associated with delivery of products to market and clinic
  3. Identify, and apply critical analysis and evaluation to, key issues in the subject area
  4. Formulate well-reasoned and coherent arguments relating to key issues in the subject area
Reading List
There is no single set text for the course, but a range of journal-based materials will be referred to.

A detailed list of key resources will be available at the start of the course.
Additional Information
Course URL
Graduate Attributes and Skills Students will develop the following skills and abilities:

1. Cognitive skills. The course will enable the student to select and deploy appropriate research techniques; they will critically analyse and evaluate key issues in the subject area, and formulate coherent arguments relating to key issues in the subject area.

2. Communications. Students will be able to summarise and communicate information and ideas effectively in oral and written form. Students are also expected to interact with each other and with tutors online, and this forms part of the overall assessment.

3. Autonomy, accountability. Students will exercise personal autonomy and intellectual initiative in, and take responsibility for, the conduct of their own work.

4. Working with others. They will engage with others through participation in online discussion: articulating and supporting a line of argument and formulating critical analyses of arguments presented by others.
Special Arrangements This course is taught by online learning.
Additional Class Delivery Information This course is taught by online learning.
Keywordsmedicine,health research,innovation,regulation,governance,public/private,commercial,economic
Course organiserDr Murray Earle
Tel: (0131 6)50 8183
Course secretaryMs Clare Polson
Tel: (0131 6)51 9704
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