Back to Basics in Pharmacovigilance

24th to 25th Feburary 2016, Whiteley, England.


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. This course provides solid practical foundations for those working in drug safety and is of benefit to staff working in pharmacovigilance departments and to a broad range of staff in the pharmaceutical industry an regulatory authorities. Attendance at this course can be used as part of the training required for Pharmaceutical Medical Specialty Training (PMST).

– 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 PDUFA III
– 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

General information

24th to 25th Feburary 2016

Get the official program here.

Course language:

Course location:
Solent Hotel
Rookery Ave
Whiteley, Fareham,
Hampshire PO15 7AJ
Vereinigtes Königreich

Get all the contact details here.

Register here.


Tip: More up to date educational events regarding „Drug Safety“ can be found online in the Education Database »medicine & health«.

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