Postgraduate Course: Pharmacovigilance (MCLM11005)
Course Outline
| School | School of Molecular, Genetic and Population Health Sciences |
College | College of Medicine and Veterinary Medicine |
| Course type | Online Distance Learning |
Availability | Not available to visiting students |
| Credit level (Normal year taken) | SCQF Level 11 (Postgraduate) |
Credits | 10 |
| Home subject area | Molecular and Clinical Medicine |
Other subject area | None |
| Course website |
None |
Taught in Gaelic? | No |
| Course description | The safety of drugs both in their development and their clinical use is of paramount importance. This module provides an introduction to Pharmacovigilance including key definitions and the nature and burden of adverse drug reactions (ADRs). It covers safety monitoring in clinical trials, what ADRs this will detect and its limitations. It will look at the methods for post-marketing surveillance, introduces patient risk management and relevant guidelines. |
Entry Requirements (not applicable to Visiting Students)
| Pre-requisites |
|
Co-requisites | |
| Prohibited Combinations | |
Other requirements | None |
| Additional Costs | None |
Course Delivery Information
|
| Delivery period: 2013/14 Semester 2, Not available to visiting students (SS1)
|
Learn enabled: Yes |
Quota: None |
Web Timetable |
Web Timetable |
| Course Start Date |
13/01/2014 |
| Breakdown of Learning and Teaching activities (Further Info) |
Total Hours:
100
(
Seminar/Tutorial Hours 5,
Online Activities 100,
Feedback/Feedforward Hours 40,
Formative Assessment Hours 12,
Summative Assessment Hours 10,
Revision Session Hours 8,
Programme Level Learning and Teaching Hours 2,
Directed Learning and Independent Learning Hours
0 )
|
| Additional Notes |
|
| Breakdown of Assessment Methods (Further Info) |
Written Exam
0 %,
Coursework
100 %,
Practical Exam
0 %
|
| No Exam Information |
Learning Outcomes
On completion of this course, the student will be able to:
1. Explain adverse events (AEs), serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs)
2. Document, report and follow-up adverse drug reactions according to known requirements
3. Recognise the role of safety reporting in the wider context of pharmacovigilance
4. Discuss the principles and practices of post-marketing surveillance |
Assessment Information
Online participation: 25%
Individual project: 25%
Reflective portfolio: 30%
Case scenarios: 20% |
Special Arrangements
| None |
Additional Information
| Academic description |
Not entered |
| Syllabus |
Not entered |
| Transferable skills |
Not entered |
| Reading list |
Not entered |
| Study Abroad |
Not entered |
| Study Pattern |
Not entered |
| Keywords | Clinical trials, safety, monitoring, adverse drug reactions, post-marketing surveillance, risk manag |
Contacts
| Course organiser | Miss Michelle Evans
Tel: 0131 537 3326
Email: michelle.evans@ed.ac.uk |
Course secretary | Mrs Danielle Marlow
Tel: 0131 537 3798
Email: Danielle.Wilson@ed.ac.uk |
|
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