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?

23 - 24 Nov 2023

On location

English

13,100 DKK ex VAT

(app. 1,761 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

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Course leader(s) & Lecturer(s)

  • Andreas Høiberg Bentsen
    Course leader
    Chief Advisor, Team Lead Healthdata
    DLI Market Intelligence ApS
  • Cathrine Tipsmark
    Lecturer
    Consultant Healthdata
    DLI Market Intelligence ApS
  • Natalie Clausen
    Lecturer
    Consultant Healthdata
    DLI Market Intelligence ApS
  • Atheline Major-Pedersen
    Lecturer
    Safety Surveillance Principal Specialist, Global Safety
    Novo Nordisk A/S
See all

Watch the video

IS THIS COURSE FOR YOU?

The course is relevant for you if you want to learn about the importance, generation and use of Real World Evidence. You work with clinical development and/or monitoring of side effects as e.g. Market Ethics Manager, Marketing Manager, Project Manager, or Clinical Development Manager.

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

Starting 23 Nov 2023
23 Nov 2023 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.
24 Nov 2023 9:00-16:00

Day 2

The agenda for the day will be annouced later
Practical information

Registration

Registration deadline
16 Nov 2023
Atrium
Lersø Parkallé 101
2100 København Ø
Register
23 - 24 Nov
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)

Andreas Høiberg Bentsen
Chief Advisor, Team Lead Healthdata
DLI Market Intelligence ApS

Lecturer(s)

Cathrine Tipsmark
Consultant Healthdata
DLI Market Intelligence ApS
Natalie Clausen
Consultant Healthdata
DLI Market Intelligence ApS
Atheline Major-Pedersen
Safety Surveillance Principal Specialist, Global Safety
Novo Nordisk A/S

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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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