Short Course
Risk Benefit Assessment in Pharmacovigilance (Online)
Venue
Online
Date
23 June 2027 - 24 June 2027
Course Overview
Risk benefit assessment occurs throughout the life cycle of the product. The Risk Benefit Assessment in Pharmacovigilance course enables delegates to explore how risks should be evaluated in the context of anticipated benefit.
Attendance at this course can be used to provide training for Pharmaceutical Medicine Specialty Training (PMST), especially to support Specialty Capabilities in Practice 6 and 7.
Who should attend
This course is aimed at:
- Pharmaceutical industry personnel from areas including pharmacovigilance, clinical research, medical affairs, medical writing, regulatory affairs and medical information
- Pharmaceutical physicians completing Pharmaceutical Medicine Specialty Training (PMST)
- Staff from regulatory authorities
How our course works
- Taught over two days online
- A combination of lectures and interactive workshops
- Interact with other delegates and speakers via scheduled discussion sessions
- Full access to PDFs and recordings of the presentations afterwards
- Use this course as part of your Continuing Professional Development (CPD)
- Delegates will be sent a Teams link in advance to enable you to join the live course at the stated time
- Certificate of attendance provided upon completion of the course
Our fees
Registration fees include electronic access to all course materials.
Please note, VAT is only applicable for delegates based in the UK.
Cost Per Delegate:
Academic
£775 + VAT
(Academic Units, Public Sector Organisations, Registered Charities)
Standard
£1190 + VAT
PMST
£1300 + VAT
Aims of the course
- To develop knowledge and understanding of the principles of risk benefit assessment, plus methods available for quantitative risk benefit analysis
- To understand sources of safety data, and the identification and evaluation of safety signals, and how risks can be measured and defined
- To understand the different activities to manage and minimise known risks including routine risk minimisation and additional risk minimisation measures
- To understand the importance of the PBRER/PSUR, and the role of the DSUR
- To explore how safety issues can be communicated and to consider how to manage a crisis
Learning outcomes
On successful completion of this course delegates should be able to:
- Analyse and evaluate a safety signal
- Undertake a risk benefit analysis of a newly marketed medicinal product, make and justify appropriate recommendations for communicating the updated information
- Differentiate between the various regulatory actions possible to address drug safety signals
- Recommend and justify options for crisis management of a safety signal
Programmed features
- Principles of risk benefit assessment and management – focus on assessment methodologies and special situations incorporating the new CIOMS Working Group XII report
- Risk benefit – a regulator’s perspective
- Practical implications of completing regulatory requirements
- Urgent re-evaluation of benefit-risk of a marketed product
- Benefit-risk assessment in Periodic Safety Reports – PBRERs and DSURs
- Communication of safety issues
Download programme
Please download the relevant programme for your chosen course date.
24 June 2026 - 25 June 2026
Book now
- 24 June 2026 - 25 June 2026
Limited places available - register early to secure your spot
Our courses are CPD accredited by the Faculty of Pharmaceutical Medicine and are recognised by PharmaTrain.