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

Postgraduate Course: Pharmacovigilance (MCLM11054)

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 Credits20 ECTS Credits10
SummaryThis optional 20-credit course is intended for students with a basic interest in pharmacovigilance and complements other courses on the Clinical Trials programme. An understanding of the regulatory framework within which activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicines, are applied.
Course description The Pharmacovigilance course builds on previous courses which highlighted the critical requirement for adverse event reporting when conducting clinical trials, and introduces the operational requirements and regulatory processes involved in the detection, assessment, understanding and prevention of adverse effects of drugs after they have been licensed for use.
Focus will be on drug safety monitoring, in accordance with national and international legislation and guidelines, as well as proactive strategies for risk management to improve patient safety.

Course participants will gain a firm understanding and international knowledge of the regulatory frameworks and processes that apply to drug safety monitoring as presented in the following 3 units over the course of 10 weeks:

- Unit 1 - History of Pharmacovigilance and Basic Definitions
- Unit 2 - Adverse Event Reporting & Global Regulation
- Unit 3 - Signal Detection & Risk Management
Entry Requirements (not applicable to Visiting Students)
Pre-requisites Co-requisites
Prohibited Combinations Other requirements None
Course Delivery Information
Academic year 2023/24, Not available to visiting students (SS1) Quota:  None
Course Start Flexible
Course Start Date 05/08/2023
Timetable Timetable
Learning and Teaching activities (Further Info) Total Hours: 200 ( Programme Level Learning and Teaching Hours 4, Directed Learning and Independent Learning Hours 196 )
Assessment (Further Info) Written Exam 0 %, Coursework 100 %, Practical Exam 0 %
Additional Information (Assessment) Coursework 100 %
Total Hours: 200 ( Seminar/Tutorial Hours 6, Online Activities 80, Feedback/Feedforward Hours 40, Formative Assessment Hours 8, Summative Assessment Hours 30, Revision Session Hours 4, Programme Level Learning and Teaching Hours 4, Directed Learning and Independent Learning Hours 28)«br /»
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Assessment is undertaken throughout the course with each element structured to provide opportunities for formative feedback at key points. Assessment is designed to be integral to the learning process and triangulates between learning outcomes, learning content and graduate attributes.
Online Participation - 20%
Individual Project I - 35%
Individual Project II - 45%
Feedback Not entered
No Exam Information
Learning Outcomes
On completion of this course, the student will be able to:
  1. Critically appraise the principles of pharmacovigilance practice and the regulatory framework for clinical drug safety
  2. Distinguish safety reporting requirements in the pre-marketing, peri-approval, and post-marketing continuum
  3. Categorise the seriousness, expectedness, and causality of adverse events
  4. Identify EU risk management plan (RMP) requirements and USA risk evaluation and mitigation strategies (REMS)
  5. Discuss methods for signal detection and data mining, and apply the principles of pharmacoepidemiology
Reading List
Key articles will be referred to at relevant points during the course.
Additional Information
Graduate Attributes and Skills Within the work to be undertaken this course will provide participants with the opportunity to develop or further develop key graduate attributes:
- In-depth knowledge of specialist discipline
- Develop new understanding by exercising critical judgement and challenging knowledge
- Be a self-directed learner
- Solve problems effectively taking ethical, professional and environmental issues into account
- Use information responsibly in a range of contexts
- Collaborate with others, capitalising on their different thinking, experience and skills
- Communicate (oral, written, online) effectively, respectful of social and cultural diversity
- Application of numeracy
- Application of IT
KeywordsPharmacovigilance; drug safety monitoring; adverse event reporting
Course organiserDr Paula Smith
Tel: (0131)242 6130
Course secretaryMs Rebecca Sewell
Tel: (0131 6)51 7112
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