Quantitative Benefit Risk Assessment for the new PSUR & Risk Minimisation 2014 is a seminar that covers topics such as:
Understanding quantitative concepts
Regulatory expectations for the new psur (pbrer):
Compliance
Implementation
Quality
System tracking
Links with RMP & Signal detection
Auditability
Statistical methods & data requirements:
Safety data
Clinical efficacy/effectiveness data
Meta-analysis of efficacy and safety data
Patient reported outcome efficacy data
Preferences and values
Statistical signal analysis
Methodologies of benefit-risk assessment
Evaluation of the positive and negative effects of additional risk minimisation plans
Planning for the new psur for new and old products in your company
Past Events
Quantitative Benefit Risk Assessment for the new PSUR & Risk Minimisation 2014 - 02 Dec 2014, Holiday Inn London Bloomsbury, United Kingdom (46946)
Important
Please, check "Quantitative Benefit Risk Assessment for the new PSUR & Risk Minimisation" official website for possible changes, before making any traveling arrangements
