Introduction

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. The relationships between pharmacovigilance plans, risk management, pharmacoepidemiology and risk minimisation programmes will be the central theme. Experts will share their personal experiences in managing the risk of bringing new medicines to market, and outline new approaches to mitigating risk and improving decision making. Group interactive sessions will analyse recent ‘real-world’ challenges faced by marketing authorisation holders and regulators.

Aims

• To critically appraise the elements of a Risk Management System through evaluation of the relationship between pharmacovigilance and risk management plans
• To prepare for construction of Safety Specification and Risk Management Plans through critical evaluation of the latest concepts in tools and strategies for risk assessment and prevention
• To critically examine current recommendations and practices of managing risk and analyse the implications for decision-making 

• Current regulation and guidance relevant to global risk management
• Safety specification and pharmacovigilance planning
• Risk management activities and the drug development programme
• Stakeholder perspectives on construction and execution of risk management plans
• Workshop to analyse recent challenges in the implementation of risk management plans
• Development of best practice techniques
• Management of drug safety after reclassification

On successful completion of this course delegates should be able to:

• Critically interpret the purposes of risk management systems in drug safety and the challenges that risk management represents
• Plan, prepare and justify Safety Specification and Risk Management Plans
• Demonstrate a critical awareness of models for safety agreements and have basic knowledge and skills required to proactively manage the development and execution of a safety agreement with a partner