>Back to Basics in Pharmacovigilance (September)
- Venue: Solent Hotel, Whiteley, Fareham
- Date: 05 Sep - 06 Sep 2018
Cost per delegate:
- Or £775 + VAT academic
(academic units, public sector organisations, registered charities)
- Or £1300 + VAT pmst
- Or £1190 + VAT standard
- Or £775 + VAT academic
Book your place
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. You can find out more about our postgraduate programme in Pharmacovigilance here.
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 click here to open the programme.
Please note that the course dates and programme may be subject to change.
The course is recognised by PharmaTrain.
“Covered wide scope and went into good level of detail per topic. ” Back to Basics delegate Feb 2017
“Experienced speakers, up-to-date material, comprehensive overview of PV.” Back to Basics delegate Feb 2017
“Brilliant course! Well organised and very informative.” Back to Basics delegate Feb 2017
“Good course that gives a good background view of pharmacovigilance, both pre and post marketing.” Back to Basics delegate Sept 2016
“Good overall content, organisation and presentations. Speakers happy to discuss/answer questions. ” Back to Basics delegate Sept 2016
- 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
- Historical aspects and evolution of drug safety
- Regulatory aspects, including the Clinical Trial Directive and FDA guidelines
- International Conferences on Harmonisation
- Collecting and reporting drug safety information
- Pharmacovigilance planning
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
Our next course
Pharmacovigilance Planning and Risk Management
A pro-active approach to risk management of drug safety is vital throughout the whole life-cycle of a medicinal product. The aim of this course is to critically explore existing and developing strategies to plan and optimise risk management activities for known and potential risks of a newly approved product.