Strengthen your HTA application with RWE

Learn how to demonstrate drug effectiveness using RWE

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2 May 2025

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On location

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English

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6,500 DKK ex VAT

(app. 874 EUR ex VAT)

50% DISCOUNT FOR PUBLIC INSTITUTIONS

Summary


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 Danish 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 one day 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.


Other course participants say

"Good, valuable information. A high academic level, but still very informative in the logical steps"

Martin


Keywords

  • 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
    Lecturer
    Biostatistical Chief Consultant
    Medicinrådet
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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

2 May 2025 9:00-16:00
  • How can Real World Evidence be used in HTA applications?
    • An overview of how Real World Evidence can be used in HTA applications
    • Introduction to Real World Evidence and study designs
    • Estimation of treatment effectiveness and sources of bias
    • Target trial emulation
    • Gathering information across studies: reporting and meta-analysis
  • Indirect comparisons
    • When are indirect comparisons relevant?
    • Methods for indirect comparisons
  • Presentation of an application to the Danish Medical Council with focus on the usage of Real World Evidence and statistical aspects
  • Building a Real World Evidence portfolio to support HTA applications
  • Group work and discussion of an example application to the Danish Medical Council with focus on the usage of Real World Evidence and statistical aspects
      Practical information

      Registration

      Registration deadline
      18 Apr 2025
      Atrium
      Lersø Parkallé 101
      2100 København Ø
      Register
      2 May
      Sometimes things change. This is the expected programme.

      Course information

      Prerequisites

      Either statistical experience or pharma experience or both.

      Examination

      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

      Lecturers

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

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      Want to know more, or need help?

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