Postgraduate Course: Ethics and Regulatory Processes in Translating Innovation from Bench to Man (LISC11086)
|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
|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 peer assessed wiki and a presentation) to answer a clinically-relevant translational challenge.
The lecture series will cover the principles of GCP/GMP, Regulatory submissions, Trial design, Ethical Board applications and general challenges in introducing technologies in to patients.
The course is split into three phases:
Phase 1 - all students will be asked to complete an online training course in Good Clinical Practice.
Phase 2 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 regulatory consultancies, clinicians, quality assurance and the pharmaceutical industry.
Phase 3 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. Students will see their mentors weekly for a maximum of one hour. 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 external lecturers.
Entry Requirements (not applicable to Visiting Students)
||Other requirements|| None
|Additional Costs|| 0
Course Delivery Information
|Academic year 2016/17, Not available to visiting students (SS1)
|Learning and Teaching activities (Further Info)
Seminar/Tutorial Hours 14,
Online Activities 6,
Programme Level Learning and Teaching Hours 3,
Directed Learning and Independent Learning Hours
|Assessment (Further Info)
|Additional Information (Assessment)
||This course will comprise of three assessed components:
All students will be required to successfully complete ICH-GCP training course online (20%)
All students will produce a WIKI to be assessed (30%)
All students will be assessed at the end of phase 2 by a presentation (50%)
Furthermore, mentors will informally assess the progress of student teams and provide feedback.
|No Exam Information
On completion of this course, the student will be able to:
- Understand an ethical/regulatory research problem from a variety of perspectives including scientific, commercial and social.
- Understand the basic principles of GCP (Good Clinical Practice)
- Critically assess other people's approaches to solving significant scientific and regulatory challenges.
- Develop a WIKI page and web-based skills to communicate knowledge of the ethical/regulatory issues
- Have a broad understanding of the ethical/regulatory challenges of translating technology from bench to man.
|Graduate Attributes and Skills
||Students must be enrolled on the PhD Optical Medical Imaging with Healthcare Innovation and Entrepreneurship (UoE lead - joint with Strathclyde) -4 Years (PRPHDOPMIH1F)
|Course organiser||Dr Kanwaldeep Dhaliwal
|Course secretary||Mrs Samantha Brown
Tel: (0131 6)51 7769
© Copyright 2016 The University of Edinburgh - 3 February 2017 4:36 am