Postgraduate Course: Ethics and Regulatory Processes in Translating Innovation from Bench to Man (LISC11087)
Course Outline
| School | Deanery of Clinical Sciences |
College | College of Medicine and Veterinary Medicine |
| Credit level (Normal year taken) | SCQF Level 11 (Postgraduate) |
Availability | Not available to visiting students |
| SCQF Credits | 20 |
ECTS Credits | 10 |
| Summary | Ethics 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.
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Entry Requirements (not applicable to Visiting Students)
| Pre-requisites |
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Co-requisites | |
| Prohibited Combinations | |
Other requirements | None |
Course Delivery Information
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| Academic year 2021/22, Not available to visiting students (SS1)
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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 )
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| Assessment (Further Info) |
Written Exam
0 %,
Coursework
100 %,
Practical Exam
0 %
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| 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. 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. Have a broad understanding of the ethical/regulatory challenges of translating technology from bench to man. (Knowledge)
- 3. Critically assess senior clinicians¿ and industry experts¿ approaches to solving significant scientific and regulatory challenges in person and in writing. (Practice)
- 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. 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)
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Additional Information
| Graduate Attributes and Skills |
Not entered |
| Keywords | Ethics Regulation Clinical |
Contacts
| Course organiser | Dr Kanwaldeep Dhaliwal
Tel:
Email: Kev.Dhaliwal@ed.ac.uk |
Course secretary | Ms Brittany Bovenzi
Tel: (0131 6)50 4830
Email: Brittany.Bovenzi@ed.ac.uk |
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