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DEGREE REGULATIONS & PROGRAMMES OF STUDY 2015/2016

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DRPS : Course Catalogue : Deanery of Molecular, Genetic and Population Health Sciences : Molecular and Clinical Medicine

Postgraduate Course: Pharmacovigilance (MCLM11005)

Course Outline
SchoolDeanery of Molecular, Genetic and Population Health Sciences CollegeCollege of Medicine and Veterinary Medicine
Credit level (Normal year taken)SCQF Level 11 (Postgraduate)
Course typeOnline Distance Learning AvailabilityNot available to visiting students
SCQF Credits10 ECTS Credits5
SummaryThe 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.
Course description Not entered
Entry Requirements (not applicable to Visiting Students)
Pre-requisites Co-requisites
Prohibited Combinations Other requirements None
Course Delivery Information
Academic year 2015/16, Not available to visiting students (SS1) Quota:  None
Course Start Semester 2
Timetable Timetable
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 )
Assessment (Further Info) Written Exam 0 %, Coursework 100 %, Practical Exam 0 %
Additional Information (Assessment) Online participation: 25%
Individual project: 25%
Reflective portfolio: 30%
Case scenarios: 20%
Feedback Not entered
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
Reading List
None
Additional Information
Graduate Attributes and Skills Not entered
KeywordsClinical trials, safety, monitoring, adverse drug reactions, post-marketing surveillance, risk manag
Contacts
Course organiserMiss Michelle Evans
Tel: 0131 537 3326
Email: michelle.evans@ed.ac.uk
Course secretaryMrs Danielle Marlow
Tel: 0131 537 3798
Email: Danielle.Wilson@ed.ac.uk
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