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 BentsenCourse leaderChief Advisor, Team Lead Healthdata
DLI Market Intelligence ApS - Cathrine TipsmarkLecturerConsultant Healthdata
DLI Market Intelligence ApS - Natalie ClausenLecturerConsultant Healthdata
DLI Market Intelligence ApS - Atheline Major-PedersenLecturerSafety Surveillance Principal Specialist, Global Safety
Novo Nordisk A/S
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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
- The different opportunities of Real World Data, sometimes called ’Big data’.
- How Real World Evidence differs from evidence from randomised clinical trials.
- How to generate Real World Data or use existing Real World Data.
- How to apply pharmacoepidemiological methods in observational (non-interventional) studies.
- How to identify and manage sources of error in observational studies.
What your company will get
- An employee who understands the many different aspects of RWE
- 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
- An employee who can analyse and evaluate pharmacoepidemiological aspects of observational studies
- An employee who can identify sources of error
Course calendar
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.
Day 2
The agenda for the day will be annouced laterRegistration
Registration deadline16 Nov 2023
Lersø Parkallé 101
2100 København Ø
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)
DLI Market Intelligence ApS
Lecturer(s)
DLI Market Intelligence ApS
DLI Market Intelligence ApS
Novo Nordisk A/S
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