Certificate Online

Real-World Evidence in Medicine Development

2 months
1900 EUR/full
1900 EUR/full
Tuition fee
Apply date
Start date


This interactive online course will give an understanding of current techniques, opportunities and challenges for the use of real-world evidence in medicine development. This is an ideal course for anyone who wishes to become familiar with key issues in the area of real-world data and wishes to broaden his/her expertise.


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, 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


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


  • Part-time
    • 2 months
    • 9 hrs/week

Start dates & application deadlines




  • Self-paced

Academic requirements

We are not aware of any academic 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

To alway see correct tuition fees
  • International

    1900 EUR/full
    Tuition Fee
    Based on the tuition of 1900 EUR for the full programme during 2 months.
  • National

    1900 EUR/full
    Tuition Fee
    Based on the tuition of 1900 EUR for the full programme during 2 months.


  • Standard fee: €1.900
  • Public sector: government, university and non-profit organizations: €950
  • GetReal (former) partner organizations: 25% discount
  • And more


Studyportals Tip: Students can search online for independent or external scholarships that can help fund their studies. Check the scholarships to see whether you are eligible to apply. Many scholarships are either merit-based or needs-based.

Our partners

Real-World Evidence in Medicine Development
Elevate Academy


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