Webinar: Evaluating the Effectiveness of Risk Management Plans in Europe
Sponsors today are challenged to properly evaluate the effectiveness of their risk minimisation activities in Europe. European Directive 2001/83/EC requires that the market authorisation holder shall “monitor the outcome of risk minimisation measures which are contained in the risk minimisation plan or which are laid down as conditions of the market authorisation.” This can apply to routine as well as additional risk minimisation activities.
Process indicators and outcome indicators should be considered when evaluating effectiveness. Whilst the evaluation will take place after there has been adequate market uptake to the medicinal product, the planning of the evaluation needs to occur prior to implementation to ensure that processes are measurable and auditable. A proactive approach to effectiveness evaluation is therefore required. Methodologies that can measure the effectiveness of various elements within a risk minimisation plan will be shared.
During this interactive webcast you will learn:
• How to address key European regulatory requirements
• Best practices to enable an effectiveness evaluation
• What methodologies can be used when assessing process and outcome indicators
• Recognize the challenges of the diverse healthcare systems and laws within the European Union
• Observe practical examples of evaluation programmes
Webinar release date: August 2014
Contact us for to discuss the latest information on Risk Management Plans.