Principles and methods of benefit-risk assessment in decision-making of medicines
Let us guide you through the Principles and methods of benefit-risk assessment in decision-making of medicines topic and get the necessary knowledge and skills to do it right
- 120 min workload
This course gives you an introduction into the principles and methods of comparative Benefit-Risk assessment and their role of benefit-risk assessment in decision-making of medicines.
This course focuses on the different qualitative frameworks and basic quantitative methods for Benefit-Risk assessment, including their potentials and limitations.
What will you learn
At the end of the course, you will be able to :
- Explain definition of benefit and risk in EMA framework
- Explain the rationale of BR frameworks and quantitative approaches in the process of decision-making (transparency, consistency, objectivity)
- Distinguish the most important BR frameworks and their key components
- Describe what BR Modeling and BR profiling is and define differences between these approaches
- Describe basic methods and outcomes of quantitative BR assessment and present merits and demerits of each approach
- Videorecorded lectures
- Lecture slides and supplemental reading materials
- Continuous individual progress assessments
- Final exam quiz
- Certificate of Completion for the course Principles and methods of benefit-risk assessment in decision-making of medicines issued by the Am2P partners
Within which Am2P Certificate
Who made this course
F. Hoffmann-La Roche Ltd
ISoP's North American chapter
How does it work
- Sign up with minimal personal information, or sign in if you already have an account
- Register to this course immediately and get access for 12 months
- Follow the different course activities at your own pace
- At the end of the course, you will pass a final examination and, upon success, you will get a Certificate of Completion for the course Principles and methods of benefit-risk assessment in decision-making of medicines!
- In case of failure, you can review course activities and retake the final examination quizzes, as long as your 12 months active period is on!
Register now and get access to the course for 12 months!
|Individual||200 € / 230 $|
|Groups||Please contact us (price discounts based on group size)|