Policy, Regulation and the Law (P02821)

? Credit Points : 10 ? SCQF Level : 11 ? Acronym : BMS-P-MED

This module will focus on the policy, regulatory and legal issues and frameworks which impact throughout all stages of the Translational research. This course makes extensive use of case studies to highlight these key issues. An outline of IP issues and challenges stemming from new technologies and approaches in Translational Medicine will be covered. This will be followed by an exploration of the regulatory issues surrounding the clinical trials process. The response of regulatory bodies such as FDA and EMEA to advanced therapies will be covered as well as the need for harmonisation of regulatory authorities to adapt to novel therapeutics and procedures. A component of this will be an analysis of patient access to new therapies in relation to bodies such as NICE. Finally, there will be exploration of the existing and emerging ethical issues that pose challenges to the success of TM and coverage of informed consent, accessing patient specific material and genomic data.

Entry Requirements

? This course is not available to visting students.

? Special Arrangements for Entry : All courses will be delivered by distance learning, using WebCT as the delivery platform. Registered students are provided with a user name and password that allows them to access a protected course web site. The website provides a variety of educational material and supports a range of approaches by the students to the material provided. Online delivery will be supported through the provision of core didactic material, multimedia tutorials and discussions with peers and tutors. The website also houses a number of interactive tutorials that allow students to work with information in a self-paced manner to test their understanding of important concepts and principles. There will also be opportunities for group based project work.

Study guides with lecture notes are available, either to be read on screen or printed by the students for private use. Selected readings from relevant journals and textbooks are also provided.

Subject Areas

Home subject area

Translational Medicine, (School of Biomedical Sciences, Schedule T)

Delivery Information

? Normal year taken : Postgraduate

? Delivery Period : Semester 2 (Blocks 3-4)

Summary of Intended Learning Outcomes

- An understanding of the policy, regulatory and ethical issues relating to Translational Medicine
- Analysis of IP issues relating to innovative technologies and approaches
- Response of regulatory authorities to advanced therapies.
- Understanding of regulations surrounding patient access and access to patient derived material
- Overview of ethical and legal issue impacting on Translatioanl Medicine