Short Course
Back to Basics in Pharmacovigilance (Online)
Venue
Online
Date
27 January 2027 - 28 January 2027
Course overview
Monitoring drug safety is a key public health function; the aim to ensure that the benefit-risk balance of a drug remains favourable throughout its entire life cycle.
Pharmacovigilance (pharma = relating to drugs, vigilance = to watch over) is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
The Back to Basics in Pharmacovigilance course provides a solid practical foundation into pharmacovigilance and its regulations.
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.
Please note, the course dates and programme may be subject to change.
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
Please note that the course dates and programme may be subject to change.
The course is recognised by PharmaTrain.
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 learn important terminology and key definitions used in pharmacovigilance
- To provide an overview of regulatory and practical aspects of pharmacovigilance in the pre-marketing stage
- To provide an overview of regulatory and practical aspects of pharmacovigilance in the post-marketing stage (e.g., Good Pharmacovigilance Practices (GVP) Modules)
- To understand regulatory reporting of adverse drug reactions, including timelines for reporting
- To explore the principles of causality in pharmacovigilance and signal detection
Learning outcomes
On successful completion of this course delegates should be able to:
- Critically appraise the founding principles of pharmacovigilance and landmark cases affecting changes to drug safety
- Explain key operational drug safety definitions
- Demonstrate good pharmacovigilance practice and locate key sources of information and documentation
- Critically discuss issues associated with global pharmacovigilance
- Analyse the stages of drug development in terms of drug safety assessment and benefit risk
- Critically explain the strengths and weakness of pharmacovigilance reporting systems
- Identify and predict future challenges in drug safety and pharmacovigilance
Programme features
- Historical aspects and evolution of drug safety
- Pharmacovigilance regulations including the Clinical Trial Regulation and GVP modules
- International Conferences on Harmonisation
- Collecting and reporting drug safety information
- Pharmacovigilance planning
Download programme
Please download the relevant programme for your chosen course date.
27 January 2027 - 28 January 2027
Book now
- 27 January 2027 - 28 January 2027
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.