The Innovative Medicines Initiative 2 Joint Undertaking (IMI2 JU) intends to establish a framework service contract to provide a central support system which will capitalise on project results generated by increasing or securing their impact and sustainability through adoption into regulatory agency guidelines or standard practice.

Extended TitleSupporting Regulatory Acceptance of IMI Results
Extended Description

The objective of the initiative is to ensure that the key results generated by IMI projects are acceptable in a research and development (R&D) context (non-clinical or clinical studies), and are therefore implemented in the regulatory practices.

The results include novel biomarkers, endpoints, outcomes, tools/methodologies, recommendations that would support development of regulatory guidance documents. This may cover different disease areas or axes of research as per the IMI Strategic Research Agenda.

The contractor will be expected to:

— identify and prioritise the relevant project results,

— identify information/data gaps that need to be addressed to complete the submission,

— support preparation of files to be submitted to the EMA and FDA, and preliminary engagement with the agencies,

— implement process, quality criteria to be replicated across all projects, etc. to secure efficiency, consistency and quality.

Deadline Date2019-12-06
Publication Date2019-10-18
CountryBelgium
Procurement StatusActive
TypeOpen procedure
Contract TypeServices
Award CriteriaThe most economic tender
Value250000.00
OrganisationInnovative Medicines Initiative 2 Joint Undertaking
Attention OfProcurement team
AddressIMI2 JU — TO 56 1049
TownBrussels
Postal Code1060
Class Code85000000
Class DescriptionHealth and social work services
SourceOffice for Official Publications of the European Communities - Tenders electronic daily (Ted)

Version of 2019-04-09

Optimising Exploitation of Regulatory Relevant IMI Results

The Innovative Medicines Initiative 2 Joint Undertaking (IMI2 JU) intends to establish a framework service contract to provide a central support system which will capitalise on project results generated by increasing or securing their impact and sustainability through adoption into Regulatory Agency guidelines or standard practice.

This support structure will be expected to:

— identify and prioritise the relevant project results,

— identify information/data gaps that need to be addressed to complete the submission,

— support preparation of files to be submitted to the EMA and FDA, and preliminary engagement with the agencies,

— implement process, quality criteria to be replicated across all projects, etc. to secure efficiency, consistency and quality.

Extended TitleOptimising Exploitation of Regulatory Relevant IMI Results
Extended Description

The IMI2 JU intends to launch an open call for tender for these services.

Publication Date2019-04-09
CountryBelgium
Procurement StatusFuture
TypeNot applicable
Contract TypeServices
Award CriteriaNot applicable
Value250000.00
OrganisationInnovative Medicines Initiative 2 Joint Undertaking
Attention OfProcurement Team
AddressIMI2 JU — TO 56 1049 Brussels, Belgium
TownBrussels
Postal Code1060
Class Code85000000
Class DescriptionHealth and social work services
SourceOffice for Official Publications of the European Communities - Tenders electronic daily (Ted)