Call for tenders' details

Tenderers are requested to note that the closing date for submission of tenders has been extended to 06/02/2018 at 12:00 and the opening of tenders will now take place on 12/02/2018 at 10:00.
Title:
Efficacy and safety studies on medicines.
Contracting authority:
European Medicines Agency (EMA)
TED publication date:
14/12/2017
Time limit for receipt of tenders:
06/02/2018
Status:
Closed
Information
EMA/2017/09/PE
Efficacy and safety studies on medicines.
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.
Services
Open procedure
Closed
Checked
Milestones
14/12/2017
30/01/2018
N/A
06/02/2018 12:00
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
Reference Notice type Publication date
2018/S 011-019945 Corrigendum 17/01/2018
2017/S 240-497343 Contract notice 14/12/2017