Review of PRAC assessed PASS evaluating risk minimisation measures (RMM) (EffectiveRMM2)

Study identification

• EU PAS number:
  EUPAS47563
• Study ID:
  47564
• Official title and acronym:
  Review of PRAC assessed PASS evaluating risk minimisation measures (RMM) (EffectiveRMM2)
• DARWIN EU® study:
  No
• Study countries:
  Netherlands
• Study description:
  This systematic review of PASS overseen or discussed by PRAC is aimed to provide a better understanding of factors associated with PASS that did not lead to a conclusion on the effectiveness of RMM, and to gain insights into factors associated with (in)effectiveness of RMM as presented in conclusive PASS.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Division of Pharmacoepidemiology & Clinical Pharmacology (PECP), Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University

Netherlands

Study timelines

Date when funding contract was signed

Planned:01/03/2022

Actual:01/03/2022

Study start date

Planned:01/04/2022

Actual:01/04/2022

Date of final study report

Planned:01/09/2022

Sources of funding

Other

More details on funding

European Medicines Agency, Utrecht University

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable