Back to Basics in Pharmacovigilance
Back to Basics in Pharmacovigilance
Venue: Solent Hotel, Rookery Avenue, Whiteley, Fareham
Date:
05 - 06 Sep 2012
Cost per delegate:
£1,050.00 + VAT
or
£685.00 + VAT (academic units, public sector organisations, registered charities)
or
£1,155.00 + VAT (PMST/HMT) *
* Includes an Assessment Support Fee of 10%.
Course Outline
Introduction
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 and regulatory authorities. Attendance at this course can be used as part of the training required for Higher Medical Training (HMT) and Pharmaceutical Medicine Specialty Training (PMST).
Aims
- 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
Key Topics
- 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
Learning Outcomes
- 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