Post on 16-Oct-2021
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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and Evaluation (Interim) (Jan. 2020)3 Guide on Methodological Standards in Pharmacoepidemiology (Revision 7)4 Draft Guidance on RCTs Generating RWE to Support Regulatory Decisions (Oct. 2020)5 Use of RWE in Single-Drug Assessments (2018)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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