Biomedical Engineering Reference
In-Depth Information
Translational
Pharmaco-
vigilance
Discovery
research
Preclinical
develop.
Clinical
Develop.
Knowledge Management
Education & Training
Predictive
pharmacology
Predictive
toxicology
Identification
of biomarkers
Patient
recruitment
Validation of
biomarkers
Benefit/risk
assessment
with regulatory
authorities
Efficacy
Safety
Figure 4.1
Schematic showing key areas where IMI activity will impact R&D process.
Governing Board
Stakeholder
Forum
Executive
Director
(+ staff)
Member
States Group
Scientific Committee
Figure 4.2
Governance structure of IMI.
The initial strategic research agenda was approved by the IMI governing
board meeting on March 3, 2008, and is available on the IMI website.
4.2.1.1 Governance
The governing and management structure of the IMI
consist of several bodies and committees, as shown in Figure 4.2. The offi cial
legal entity formed by the EFPIA and the EC is called the IMI Joint
Undertaking (JU) and is responsible for implementation of the IMI program.
It is comprised of the IMI executive offi ce, the IMI governing board, and the
IMI scientifi c committee.
The executive offi ce is really a neutral third party with three main
functions:
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