Strengthen your HTA application with RWE

Learn how to demonstrate drug effectiveness using RWE

26 Sep 2023

On location


5,800 DKK ex VAT

(app. 780 EUR ex VAT)



How do you compare medicines in the best and most comprehensive way?

In addition to traditional clinical trials, Real World Evidence (RWE) has become a central basis for such comparators.

Scientific evidence based on data collected from sources other than traditional clinical trials, e.g. electronic health records, has become decisive when the effectiveness and safety of medicinal products is assessed, e.g. in connection with applications to the Medicines Council.

Methodologically, making comparisons between drugs, however, can be a challenging task. First, it is crucial to choose the appropriate method for the research question and the characteristics of the data being analysed. Second, it is important to consider the limitations and assumptions of each method to ensure that the analysis is conducted and interpreted correctly. Thus, insight into the RWE methodology used is essential.

This course gives you an overview of different statistical approaches for making effectiveness comparisons between drugs. This includes both how to make direct and indirect comparisons of effectiveness of treatment options in real-world settings, and how to create synthetic control arms.


  • Market access
  • Real World Evidence (RWE)
  • Statistical analysis
  • Evidence generation
  • HTA evaluations

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Course leader & lecturers

  • Klaus Kaae Andersen
    Course leader
    Director & Senior Statistician
    Omicron ApS
  • Christian Dehlendorff
    Biostatistical Chief Consultant
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Is this course for you?

This course is for health economists, statisticians, and others working with HTA applications and generation of RWE.

What you will learn

  1. How real-world data (RWD) can be used in comparison of the effectiveness of drugs.
  2. Common epidemiological designs used to generate RWE for comparative studies.
  3. Common methods used for making direct comparisons and interpretation of effects.
  4. Methods used for indirect treatment comparisons, pitfalls, and interpretation.

What your company will get

  1. An employee who knows how to generate direct and indirect comparisons of drugs using real world data.
  2. An employee who can choose the right RWE method for the specific purpose and set up the right experimental design.
  3. An employee who can advise colleagues on opportunities and limitations of RWE.

Course calendar

26 Sep 2023 9:00-16:00
  1. Introduction to RWE and study designs.
  2. Evaluation of treatment effectiveness and sources of bias.
  3. Gathering information across studies: meta-analysis.
  4. Performing indirect comparisons.
  5. Creating synthetic control arms, including hands-on examples from rare diseases area or Phase II studies.

    Practical information


    Registration deadline
    19 Sep 2023
    Lersø Parkallé 101
    2100 København Ø
    26 Sep
    Sometimes things change. This is the expected programme.

    Course information


    Either statistical experience or pharma experience or both.


    Not relevant. 

    This course is a part of a diploma

    Diploma in Market Access

    Our Diploma in Market Access provides you with in-depth knowledge of the Danish healthcare system and its funding models and stakeholders. Raise your skill level in areas such as public affairs, stakeholder management and health economics by attending the four courses

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    Course leader

    Klaus Kaae Andersen
    Director & Senior Statistician
    Omicron ApS


    Klaus Kaae Andersen
    Director & Senior Statistician
    Omicron ApS
    Christian Dehlendorff
    Biostatistical Chief Consultant

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    Want to know more, or need help?

    Contact Client Manager Ida Salicath at +45 39 15 09 46