Postgraduate Course: Pharmacovigilance (MCLM11005)

Course Outline
School	Deanery of Molecular, Genetic and Population Health Sciences	College	College of Medicine and Veterinary Medicine
Credit level (Normal year taken)	SCQF Level 11 (Postgraduate)
Course type	Online Distance Learning	Availability	Not available to visiting students
SCQF Credits	10	ECTS Credits	5
Summary	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.
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 2017/18, 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: Explain adverse events (AEs), serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs) Document, report and follow-up adverse drug reactions according to known requirements Recognise the role of safety reporting in the wider context of pharmacovigilance Discuss the principles and practices of post-marketing surveillance