Call for tenders' details
Information
Tender reference number
EMA/2017/09/PE
Title
Efficacy and safety studies on medicines.
Description
Post-authorisation effectiveness and pharmacoepidemiology studies to generate data and information to support regulatory decision-making. Research may also focus on the effectiveness of regulatory measures taken and on the impact of relevant legislation. The range of research topics is limited to those with high public health relevance and with a European impact. The scope of the funding covers both nationally and centrally authorised products, including vaccines. The results obtained from this research will subsequently be assessed by the responsible agency committee regarding the need for regulatory action and further research may subsequently also be conducted to measure the effectiveness of regulatory actions taken. The research may concern four different lots, with a maximum of five framework contracts for lots 1, 2 and 3 and a maximum of 8 framework contracts for lot 4.
Contract type
Services
Procedure type
Open procedure
Status
Closed
Published on TED
Milestones
TED publication date
14/12/2017 00:00
Question deadline
30/01/2018 22:59 UTC+01:00
Answer deadline
N/A
Time limit for receipt of tenders
06/02/2018 12:00
Conditions for opening tenders (date)
12/02/2018 10:00
Lots
Lot number
Title
Description
Lot 1
Use of innovative methods to optimise the utility of sparse data to support benefit /risk assessment
For full description please see section 3.2 of the technical specifications (procurement documents).
Lot 2
Qualitative research
For full description please see section 3.2 of the technical specifications (procurement documents).
Lot 3
Pharmacoepidemiology research — rapid descriptive studies
For full description please see section 3.2 of the technical specifications (procurement documents).
Lot 4
Pharmacoepidemiology research — association studies, including pregnancy and breastfeeding research.
For full description please see section 3.2 of the technical specifications (procurement documents).
Notices