THE UNIVERSITY of EDINBURGH

DEGREE REGULATIONS & PROGRAMMES OF STUDY 2021/2022

Information in the Degree Programme Tables may still be subject to change in response to Covid-19

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DRPS : Course Catalogue : Deanery of Clinical Sciences : Life Sciences

Postgraduate Course: Ethics and Regulatory Processes in Translating Innovation from Bench to Man (LISC11087)

Course Outline
SchoolDeanery of Clinical Sciences CollegeCollege of Medicine and Veterinary Medicine
Credit level (Normal year taken)SCQF Level 11 (Postgraduate) AvailabilityNot available to visiting students
SCQF Credits20 ECTS Credits10
SummaryEthics and Regulatory Processes in Translating Innovation from Bench to Man is a course which blends formal lectures, mentorship and a problem-based learning exercise.
The course will comprise 6 hours of lectures and an exercise with 2 assessed components (a wiki and a presentation) to answer a clinically-relevant translational challenge.
In addition students will complete online training in GCP principles run by Whitehall Training.
The lecture series will cover the principles of GCP/GMP, Regulatory submissions, Trial design, Ethical Board applications and general challenges in introducing new technologies in a clinical setting.
Course description The course is split into two phases:

Phase 1 is an intensive one-day workshop mixing formal lectures by external experts with Q&A sessions and group discussions.
Lectures will be delivered by expert speakers from clinical medicine, regulatory consultancies, quality assurance and the pharmaceutical industry.

Phase 2 is a 6 week problem-based exercise where students in small groups are tasked with the generation of a WIKI page detailing the context and suggested approach for an ethical/regulatory issue in technology development. Each group will be assigned a staff mentor. The students will present their wiki to their peers and mentors to assess their approaches to the regulatory challenge. The assessment will generate new ideas and provide feedback to the students to refine and improve their strategy before they make their final presentation. The final presentation will be judged by the students¿ mentors and the expert lecturers. After the presentations the students will receive further feedback from the assessment panel.
Entry Requirements (not applicable to Visiting Students)
Pre-requisites Co-requisites
Prohibited Combinations Other requirements None
Course Delivery Information
Academic year 2021/22, Not available to visiting students (SS1) Quota:  20
Course Start Semester 1
Timetable Timetable
Learning and Teaching activities (Further Info) Total Hours: 200 ( Lecture Hours 3, Seminar/Tutorial Hours 14, Online Activities 6, Programme Level Learning and Teaching Hours 4, Directed Learning and Independent Learning Hours 173 )
Assessment (Further Info) Written Exam 0 %, Coursework 100 %, Practical Exam 0 %
Additional Information (Assessment) This course will comprise of two assessed components:
All students will produce a WIKI to be assessed (30%)
All students will be assessed at the end of phase 2 by a presentation (70%)
Furthermore, mentors will informally assess the progress of student teams and provide feedback.
Feedback Not entered
No Exam Information
Learning Outcomes
On completion of this course, the student will be able to:
  1. 1. Understand the basic principles of Good Clinical Practice and an ethical/regulatory research problem from a variety of perspectives including scientific, commercial and social. (Knowledge)
  2. 2. Have a broad understanding of the ethical/regulatory challenges of translating technology from bench to man. (Knowledge)
  3. 3. Critically assess senior clinicians¿ and industry experts¿ approaches to solving significant scientific and regulatory challenges in person and in writing. (Practice)
  4. 4. Work effectively and in a self-directed manner in a team to develop a regulatory approach to a defined clinical application. (Autonomy, working with others)
  5. 5. Develop a WIKI page and web-based skills to communicate knowledge of the ethical/regulatory issues and communicate their team¿s findings to industry experts and answer key questions on their approach and results (Communication/ICT/Practice)
Reading List
None
Additional Information
Graduate Attributes and Skills Not entered
KeywordsEthics Regulation Clinical
Contacts
Course organiserDr Kanwaldeep Dhaliwal
Tel:
Email: Kev.Dhaliwal@ed.ac.uk
Course secretaryMs Brittany Bovenzi
Tel: (0131 6)50 4830
Email: Brittany.Bovenzi@ed.ac.uk
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