Structured benefit-risk assessment of medicinal products

This self-paced course will provide an understanding of current techniques, opportunities and challenges of structured benefit-risk assessment, including different preference elicitation techniques. It is therefore intended for anyone who wishes to extend their knowledge on structured benefit-risk assessment with a specific focus on multi-criteria decision analysis, from prescribing physicians to industry, regulatory and other professionals.

Prof. dr. J.L. (Hans) Hillege
Professor in Cardiology, UMCG
Prof. dr. J.L. (Hans) Hillege
  • 20 hours on average
  • English
  • Self-paced
  • Online
  • English
€ 1.100,- ex. VAT (see 'Course fees & enrollment' for discount)
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Course description

The evaluation of the benefit–risk balance is a key element across the entire life cycle of a medicinal product. Intuitive, implicit benefit–risk assessment methods have evolved towards more structured approaches. A structured benefit–risk assessment aims at providing a transparent assessment of the benefit–risk profile of medicinal products by making explicit the underlying assumptions and value trade-offs. Several quantitative and semi-quantitative methodologies have been developed and utilized to complement descriptive or qualitative frameworks in order to facilitate the structured evaluation of the benefit–risk profile of medicinal products.

Although combining key benefits and risks into a single metric have historically only been conducted for the “average” patient, such aggregate assessments may also provide helpful information on the level of an individual patient. Furthermore, there is an increasing interest on the use of real-world data to substantiate benefit-risk assessment and support a more patient-centered approach and the value of a new treatment options in daily practice.

This course consists of three self-paced learning units, starting with an introduction to benefit-risk, followed by learning units on decision making styles and multiple-criteria decision analysis. After the course participants are asked to complete a final assignment (optional), in which participants will conduct a benefit-risk assessment. The course takes on average 20 hours to complete.

An overview of the learning units of this course:
• Introduction to Benefit-Risk Assessment
• Decision Making Styles
• Multiple-criteria Decision Analysis
• Final Assignment

Interested in this course? Check out the teaser-video below!

Learning objectives

This course consists of two core learning units, each with different learning objectives.

At the end of Learning Unit 1: ‘Decision making styles’ you will be able to:
• Recognize the complexity of a benefit risk comparison.
• Familiarize with structured decision making.
• Describe how patient perspectives are incorporated in regulatory decision making.
• Design an effects table.
• Recognize the different steps in a decision aiding process by means of a structured benefit-risk assessment.
• Describe what factors are involved in benefit-risk comparison.

At the end of Learning Unit 2: ‘Multiple-criteria decision analysis’ you will be able to:
• Describe how complex decision problems can be addressed and resolved through the specification of value trade-offs.
• Describe and interpret the two components of the additive value model (i.e., the weights and the partial value functions).
• Describe how clinical data on efficacy and safety can be combined with an elicited value function to perform a quantitative benefit-risk assessment (qBRA).
• Describe how stochastic multi-criteria acceptability analysis can be applied to account for uncertainty in the data and imprecision in the preferences.

Learning methods

Interactive online learning via the platform of Elevate Health
The online course is available through Elevate Health’s Virtual Learning Environment. The course is designed as a self-paced module. You can learn from GetReal top experts, through web lectures as well as individual assignments, case studies and self-tests.

The course has no set start date. The total average workload is around 20 hours. You will be able to study at your own pace and convenience. It is not required to participate in the course during specific moments of the day.

Advantages of an online course
• Flexibility and efficiency: there is no need to travel to attend a lecture, so you can spend your time very efficiently. 
• Personalized learning: you can study at your own pace and choose which form of guidance works best for you.
• Personal feedback on your final assignment (optional) from two experts.

Learning tools
This course consists of weblectures, case assignments, self-tests, reading assignments and, stimulating questions.

For whom?

• Participants distributed over the whole medicine development chain:  from academic researchers to industry, regulatory and other professionals.
• No diplomas are required for enrollment, but the course is aimed at participants who have an advanced level of understanding of benefit-risk in drug development. Familiarity with regulatory science and medicines development is recommended.
• The course will be taught in English. To successfully participate, sufficient proficiency in English reading and writing is required.

Course fees

• Standard fee: €1.100 ex. VAT
• Public sector: government, university and non-profit organizations: €550 ex. VAT
• Members of the GetReal Institute: 25% discount
• Groups: 10% discount for the enrollment of 4 participants (non-GetReal members only)

Please contact us at to request a discount code for the public sector fee (€550) and/or a member of the GetReal Institute or group 10% discount code.

Wij zijn Elevate

Wij geloven dat futureproof onderzoek essentieel is voor goede zorg. Daarom verbinden we innovatieve medische kennis met didactiek. Dankzij ons uitgebreide netwerk en bewezen didactische methodes, maken we Health & Life Sciences professionals beter dan gisteren.

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