Collecting high quality ADR reports
Course
Attention, course certificates will only be awarded to professionals working in national or regional pharmacovigilance centres.
The aim of this course is to introduce key concepts and strategies that will support effective collection of high quality ADR reports prior to their subsequent analysis in your pharmacovigilance center.
Please bear in mind that this course was originally developed for staff members of national and regional pharmacovigilance centres. If you work in another type of organisation, some aspects of the topics presented might be less relevant for you.
It takes approximately 3 h to complete this course.
Course syllabus
- ADR - mechanisms, types and risk factors
After the session you will be able to:
- describe different mechanisms that result in adverse drug reactions
- explain the classification of ADRs (type A, type B, and other classifications)
- identify risk factors for ADRs
- Developing a positive ADR reporting culture
After the session you will be able to:
- list the main reasons that motivate people to report ADRs
- identify the elements that contribute to a positive ADR reporting culture
- describe actionable strategies to promote ADR reporting
- Ways to collect ADR reports
After the session you will be able to:
- list aspects to consider when designing ways to collect ADRs
- identify positive elements and limitations in your national ADR reporting form
- Patient reporting
After the session you will be able to:
- discuss what patient reports add to pharmacovigilance
- describe best practices in patient reporting systems
- discuss what a patient reporting system looks like, and how to make it successful
- Quality of ADR reports
After the session you will be able to:
- explain the importance of collecting well-documented ADR reports
- describe the impact of quality on assessments
- identify ADR reports of high quality
- Harmonisation and standardization
After the session you will be able to:
- explain the role of the ICH as a global partner in harmonisation
- describe the E2B standard and how it can be used to facilitate data exchange
Here is the course outline:
Introduction- Introduction to the course |
Module 1- ADR-mechanisms, types and risk factors - Developing a positive reporting culture |
Module 2- Ways to collect ADR reports - Patient reporting |
Module 3- Quality of ADR reports - Harmonisation and standardisation - Evaluation |
Completion
The following certificates are awarded when the course is completed:
 |
Certificate of completion ENG 3 hour |