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• GetReal Institute

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2013-2017 June 2018 – April 2021 28 April 2021

Asia-Pacific

FDAChina CDE EMA-ENCePP MHRACADTH

RWE Navigator

ADDIS

TrialTool

GetReal Academy

1 Use of RWD/RWE to Inform Clinical Trial Design (Sept. 2019)2 Guideline on Using RWE to Support Drug Research & Development and Evaluation (Interim) (Jan. 2020)3 Guide on Methodological Standards in Pharmacoepidemiology (Revision 7)4 Draft Guidance on RCTs Generating RWE to Support Regulatory Decisions (Oct. 2020)5 Use of RWE in Single-Drug Assessments (2018)

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European forum for all-stakeholder dialogue, consensus

development, and co-creation

2. ‍Clarify‍scientific‍and‍operational‍uncertainties‍in‍approaches‍and‍methods‍

3. Facilitate adoption of best practices

4. Elevate RWE generation and evaluation capabilities

1. Serve as a principal European forum

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2. Clarify scientific and operational uncertainties•

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3. Facilitate adoption of best practices

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4. Elevate RWE generation and evaluation

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>60 million >16 million Median 10

years

follow-up

25% 20 years

follow-up

GP Network

Linked to a range of other data sources

To make an active contribution to increasing the quality of real-world evidence

(RWE) generation in medicines development and regulatory/HTA processes across

Europe.

To share ideas, experiences and new and novel ideas around the effective use of

RWE to improve public health.

www.getrealtrialtool.eu

Academic PI

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Scientific/HTA advisor

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Pharma Manager clinical trial design team

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Common denominator when assessing, considering, designing or conducting a clinical trial with RWE elements:

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GetReal Institute

Overview

courses

In

d

ep

th

courses

In

divid

ual m

od

ules

‘In

h

ouse’ courses

Tailored

courses

GetReal Academy

Different offerings

• Overview courses: give broad understanding of

RWE (50 hours)

• In-depth courses: specialised training in a specific

topic (+/- 20 hours)

• Individual modules: learning unit component of

courses, may in the future be offered á la carte (8-

10 hours)

• ‘In house’ training: running courses specifically

for one organisation

• Tailored courses: bespoke course can be

developed based on client needs and materials

available

All courses make use of a well-established e-learning

environment (Elevate Health). All courses can be

delivered fully online.

The GetReal Academy providing a comprehensive and up-to-date RWE courses

for professionals worldwide

Target audience:

Course level:

Course Structure:

Objective

Learning units

participants

(selection):

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Benefit-risk assessment

Duration:

Focus:

Delivery method:

First edition:

Pragmatic trials

Duration:

Focus:

Delivery method:

First edition:

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