Overview
The course consists of 5 Learning Units, running over a period of approximately 8 weeks. Each Learning Unit requires 8-10 hours of student input. Please note that this course is designed for those with some familiarity with the development process for medicines.
The course aims to give an overview of various concepts, approaches and techniques in real-world evidence generation. It is not designed to provide detailed training on specific methods (analytical techniques and study designs).
At the end of the course in Real-World Evidence in Medicine Development offered by Elevate Academy, you will be able to:
• Describe the medicine development chain and perspectives of various stakeholders on this chain
• Explain the factors that may affect the effectiveness of a new medicine in real life
• Explain existing designs for efficacy and effectiveness studies and how to evaluate those
• Explain the relationship between the study design choices of a relative effectiveness study and the value of information for marketing authorization at HTA
• Describe the operational challenges (including ethical, regulatory and legal aspects) of relative effectiveness studies
• Describe the existing current methods in evidence synthesis and the methods that can be applied for predictive medicine effectiveness modeling (incorporating real-world evidence)
• Understand how to integrate thinking about real-world evidence into medicine development and decision-making
• Communicate policy options around relative effectiveness, real-world evidence and various study designs
Accreditation
Real-World Evidence in Medicine Development was developed as part of the IMI GetReal project (2013-2017), and is offered by the UMC Utrecht on a non-profit basis.
Programme Structure
Course Learning Units will cover the following topics:
- Overview of the medicine development landscape
- Real-world evidence generation
- Real-world evidence synthesis
- Decision-making and weighing of evidence
- Demonstrating relative effectiveness to decision-makers
Key information
Duration
- Part-time
- 1 days
Start dates & application deadlines
Language
Delivered
- Self-paced
Disciplines
Biomedical Science Medicine Health Sciences View 11 other Short Courses in Health Sciences in NetherlandsWhat students do after studying
Academic requirements
We are not aware of any specific GRE, GMAT or GPA grading score requirements for this programme.
English requirements
We are not aware of any English requirements for this programme.
Other requirements
General requirements
- No diplomas are required for enrollment, but the course is aimed at participants who have obtained an MSc degree.
- The course will be taught in English. To successfully participate, sufficient proficiency in English reading and writing is required.
- Some familiarity with biomedical research/medicines development is highly recommended.
- Sufficient time should be available. Based on prior experience with the course and feedback from participants, 8-10 hours should be allocated to the course each week. This level of intensity will make the course of most value to participants.
Tuition Fee
-
International
800 EUR/fullTuition FeeBased on the tuition of 800 EUR for the full programme during 1 days. -
EU/EEA
800 EUR/fullTuition FeeBased on the tuition of 800 EUR for the full programme during 1 days.