The focus of this training will be on providing an update of ongoing activities regarding the benefit risk assessment throughout the lifecycle of a medicinal product. We will discuss the comprehensive framework on benefit-risk of medicinal products and participants will learn about the main principles, legal, and regulatory basis for benefit-risk obligations and frameworks for compliance. Also, we will discuss the fundamentals of benefit-risk assessment, including the different methods and frameworks (i.e. Qualitative and Quantitative) to assess the benefit-risk ratio of each medicinal product. Moreover, participants will have the opportunity to get an insight on real life examples on benefit risk assessment and evaluation and will be able to apply the key concepts learned to conduct a benefit-risk assessment and select the appropriate tools to optimize benefit-risk balance for their products.
- Understand the relative advantages/disadvantages of different methods in benefit-risk management in order to apply the most suitable approach to their issues at hand
- Gain sufficient experience in the hands-on performance of various types of benefit-risk analyses to be able to critically evaluate results from such exercises
- Learn how to use the results from such analyses in benefit-risk communication as well as in decision making
Who should attend?
- Drug safety and pharmacovigilance
- Safety evaluation
- Periodic safety reporting
- Risk management planning and development of formal Risk Management Plans/REMS
- Medical writers
- Regulatory strategy and regulatory affairs
- Clinical research
- Medical Affairs