PMST, Short Course, Postgraduate Qualifications
Back to Basics in Pharmacovigilance (Hybrid Event)
6 September 2023
Solent Hotel, Whiteley, Fareham
Course OverviewDownload course programme
Back to Basics in Pharmacovigilance is a course designed to provide solid practical foundations for those working in drug safety. This course will benefit staff working in pharmacovigilance departments and will be of interest to a broad range of staff in the pharmaceutical industry and regulatory authorities.
Monitoring drug safety is very important to public health. Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. Those working in pharmacovigilance must have a good working knowledge of the principles of drug safety, its regulations and proactive strategies for risk management.
The Back to Basics in Pharmacovigilance course is one of the three DSRU courses which comprise the Drug Safety Surveillance module of the PMST and can be used by pharmaceutical physicians as part of that training if required. This course is also one of the three compulsory units from our PgC/PgD in Pharmacovigilance run in collaboration with the University of Portsmouth.
*Please note that the course dates and programme may be subject to change.
The in-person session of this course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified at least three weeks prior to the course.
Our courses are recognised by PharmaTrain.
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 the Drug Safety Surveillance module of 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 courses work
- Taught over two days
- A combination of lectures and interactive workshops
- Network with other delegates and speakers via scheduled discussion sessions (virtual delegates), and during coffee and lunch breaks (in-person delegates)
- Full access to PDFs of the presentations afterwards
- Use this course as part of your Continuing Professional Development (CPD)
- Virtual delegates will be sent a link in advance to enable you to join the live course at the stated time
Aims of the course
- To provide delegates with a historical perspective of pharmacovigilance
- To explore the principles of causality
- To ensure an understanding of basic terminology and provide definitions of key concepts
- To introduce delegates to current key regulatory requirements, both local and international
- To introduce delegates to the concept of benefit risk in pre-marketing development
- To provide an awareness of the evolution of systems of reporting
On successful completion of this course delegates should be able to:
- Critically appraise the founding principles of pharmacovigilance and landmark cases effecting change to recent drug safety issue
- 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
- Historical aspects and evolution of drug safety
- Regulatory aspects, including the Clinical Trial Directive and GVP modules
- International Conferences on Harmonisation
- Collecting and reporting drug safety information
- Pharmacovigilance planning
Please note, VAT is only applicable for delegates based in the UK.
Cost Per Delegate:
(Academic Units, Public Sector Organisations, Registered Charities) - In-Person
£620 + VAT
£1190 + VAT
£952 + VAT
£1300 + VAT
£1040 + VAT
Registration fees include electronic access to all course materials.