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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47564
• 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 institution and networks

Institutions

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

Netherlands

Contact details

Helga Gardarsdottir

Study contact

[e-mail]

Helga Gardarsdottir

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned: 01/03/2022

Actual: 01/03/2022

Data collection

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