Create value with Real World Evidence (RWE)

How can your company make use of the large amount of Real World Data available to generate evidence to support development, market access and safety surveillance?

7. Dec 2021
1. Nov 2022

1 day course

English

5,500 DKK ex VAT
(app. 739 EUR ex VAT)
50% DISCOUNT FOR PUBLIC INSTITUTIONS

Summary

This course provides you with an understanding of how Real World Evidence (RWE) can complement evidence from randomised clinical trials and market research. You learn how to choose study design and data sources depending on the purpose of the study and how you may avoid or limit the impact of the sources of error in observational research.

You also learn about the boundaries between interventional clinical trials, observational clinical studies and market research – and the regulatory requirements for the different categories.

   

Keywords

  • Real World Data (RWD)
  • Real World Evidence (RWE)
  • Epidemiology
  • Pharmacoepidemiology
  • Observational studies
  • Non-interventional studies
  • Market access

Hi! Do you need help choosing the right course?

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Course leader(s) & Lecturers

  • Arun Micheelsen
    Course leader
    Chefkonsulent
    DLI Market Intelligence ApS

IS THIS COURSE FOR YOU?

This course is relevant for you if you want to learn about the importance of and the generation of Real World Evidence. You could be working in the medical industry in areas of health economics, pricing market access, regulatory affairs or pharmacovigilance.

What you will learn

  1. The different opportunities of Real World Data, sometimes called ’Big data’.
  2. How Real World Evidence differs from evidence from randomised clinical trials.
  3. How to generate Real World Data or use existing Real World Data.
  4. How to apply pharmacoepidemiological methods in observational (non-interventional) studies.
  5. How to identify and manage sources of error in observational studies.

What your company will get

  1. An employee who understands the many different aspects of RWE
  2. An employee who understands the pros and cons of various study designs for generating RWE and who is competent in providing input to study designs for various study objectives
  3. An employee who can analyse and evaluate pharmacoepidemiological aspects of observational studies
  4. An employee who can identify sources of error

Course calendar

Choose your starting date
Starting 7. Dec 2021
Starting 1. Nov 2022
7. Dec 2021 8:30-17:00

DAY 1

  • Introduction to key concepts and challenges
    • Real World Data (RWD)
    • Real World Evidence (RWE)
    • Customer Perspective
    • Interdisciplinary/academic cooperation
  • From RWD to RWE
  • Epidemiology and Pharmacoepidemiology:
    • Causality
    • Study design: case-control, cohort studies, cross sectionel studies
    • Endpoints
    • Sources for error: bias and confounding
  • Observational studies (Non Interventional Studies)
    • Study designs: selection of design depending on purpose
    • Primary data
    • Secondary data, incl. collaboration partners
    • Study examples
  • Short introduction to the relevant sources of law, e.g. field of application and definitions of relevant terms.
Practical information

Registration

Registration deadline
30. Nov 2021
Atrium
Lersø Parkallé 101
2100 København Ø
1. Nov 2022 9:00-16:00

DAY 1

  • Introduction to key concepts and challenges
    • Real World Data (RWD)
    • Real World Evidence (RWE)
    • Customer Perspective
    • Interdisciplinary/academic cooperation
  • From RWD to RWE
  • Epidemiology and Pharmacoepidemiology:
    • Causality
    • Study design: case-control, cohort studies, cross sectionel studies
    • Endpoints
    • Sources for error: bias and confounding
  • Observational studies (Non Interventional Studies)
    • Study designs: selection of design depending on purpose
    • Primary data
    • Secondary data, incl. collaboration partners
    • Study examples
  • Short introduction to the relevant sources of law, e.g. field of application and definitions of relevant terms.
Practical information

Registration

Registration deadline
25. Oct 2022
Atrium
Lersø Parkallé 101
2100 København Ø
Sometimes things change. This is the expected programme.

Course information

Literature

Prior to the course you will get access to mandatory and optional readings via your personal Atrium log-in.

Please familiarize yourself with the mandatory readings before starting the course.

Examination

There is no examination for this course.

Course leader(s)

Arun Micheelsen
Chefkonsulent
DLI Market Intelligence ApS

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WANT TO KNOW MORE or need help?

Contact Client Manager Christina Spangsberg at +45 39 15 09 22

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