Innovative Medicines Initiative (IMI)

This sponsor has funded 22 studies across 22 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
2353 Finalised Not included in RMP The risk of acute liver injury associated with the use of antibiotics. A methodological comparison across epidemiological data sources Yes No
2356 Finalised Not included in RMP Use of antiepileptics and risk of suicidality. An exploratory study using the UK General Practice Research Database (GPRD) and data from the Danish... Yes Yes
2382 Finalised Not included in RMP Use of antidepressants and risk of hip/femur fracture. A methodological comparison across data sources and epidemiological design Yes No
2385 Ongoing Unspecified Use of benzodiazepines and risk of hip/femur fracture. A methodological comparison across data sources and epidemiological design. Yes No
2388 Ongoing Unspecified Calcium channel blocker treatments and cancer risk. A methodological protocol to compare the results between databases, across designs: Evaluation of... Yes No
2561 Ongoing Unspecified Use of inhaled long acting beta2 adrenoceptor agonists and the risk for Acute Myocardial Infarction (AMI). A methodological comparison across data... Yes No
13766 Finalised Not included in RMP Testing new approaches to monitoring benefit/risk with pertussis vaccines as test case: Incidence rates of pertussis and pertussis related outcomes of... Yes Yes
13779 Finalised Not included in RMP ADVANCE POC I Risk pillar - Testing new approaches to monitoring benefit/risk with pertussis vaccines as test case: Incidence rates of safety outcomes... Yes Yes
13908 Finalised Not included in RMP ADVANCE POC Study Protocol - Testing new approaches to monitoring benefit/risk with pertussis vaccines as test case. Coverage rates of acellular and... Yes Yes
13978 Finalised Not included in RMP ADVANCE POC I Benefit-Risk pillar – testing new approaches to monitoring benefit/risk with pertussis vaccines as test case: benefit-risk analysis of... Yes Yes
26809 Ongoing Not included in RMP ADVANCE Proof-of-Concept study (POC):Testing a system for near real-time monitoring of vaccination coverage, benefits and risks in Europe with... Yes No
27851 Planned Not included in RMP Exposure and coverage to routine schedule vaccines in different EU countries (ADVANCE-POC2) Yes No
29817 Finalised Not included in RMP DRIVE - Brand-specific influenza vaccine effectiveness in Europe, season 2018/19 (DRIVE 2018/19) Yes Yes
35685 Finalised Not included in RMP DRIVE - Brand-specific influenza vaccine effectiveness in Europe, season 2019/20 (DRIVE 2019/20) Yes Yes
38841 Planned Not included in RMP Analysis of pregnancy pharmacovigilance data in spontaneous reports, and literature, (Individual Case Safety Reports originating from published case... Yes No
40875 Finalised Not included in RMP DRIVE Brand-specific influenza vaccine effectiveness in Europe, season 2020/21 (DRIVE 2020/21) Yes Yes
43300 Ongoing Not included in RMP Long-term investigation following exposure to individual medicines in utero: The LIFETIME system Yes No
43370 Planned Not included in RMP Building a pregnancy pharmacovigilance model for the future: Can pregnancy data collected by ConcePTION partners be analysed using common standards... Yes No
43393 Ongoing Not included in RMP Studying drug exposure when disease is measured through accurate identification of an incident case: application to breast cancer in pregnancy... Yes No
43409 Planned Not included in RMP Demonstrating solutions for studying intermittent medication exposures in diseases with episodic manifestations during pregnancy: application to... No No
44505 Planned Not included in RMP Demonstration study 2.5.5 of the ConcePTION project; Validation of primary source pregnancy exposure and outcomes (pharmacovigilance data) No No
46888 Finalised Not included in RMP DRIVE - Brand-specific influenza vaccine effectiveness in Europe, season 2021/22 (DRIVE 2021/22) Yes Yes

PAS by Risk Management Plan (RMP) requirement

Innovative Medicines Initiative (IMI)

The RMP for a medical product outlines strategies to identify, assess, and mitigate risks, including PAS for further evaluation.

Category 1 studies are imposed as condition of marketing authorisation.
Category 2 studies are imposed as specific obligation of marketing authorisation.
Category 3 studies are required under other circumstances.