Impact of medicines regulatory interventions in Europe: a systematic review focusing on unintended consequences, data used and methodology

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47826
• EU PAS number:
  EUPAS47825
• Study ID:
  47826
• Official title and acronym:
  Impact of medicines regulatory interventions in Europe: a systematic review focusing on unintended consequences, data used and methodology
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Bulgaria

  Croatia

  Cyprus

  Czechia

  Denmark

  Estonia

  Finland

  France

  Germany

  Greece

  Hungary

  Iceland

  Ireland

  Italy

  Latvia

  Liechtenstein

  Lithuania

  Luxembourg

  Malta

  Netherlands

  Norway

  Poland

  Portugal

  Romania

  Slovakia

  Slovenia

  Spain

  Sweden

  United Kingdom
• Study description:
  The goal is to perform a comprehensive assessment of studies that evaluate the impact of pharmacovigilance regulatory interventions in the European Economic Area (EEA), focusing on identifying unintended consequences and highlighting the methodology and data used.
• 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: 01/09/2021

Actual: 01/09/2021

Data collection

Planned: 01/01/2022

Actual: 13/12/2021

Date of final study report

Planned: 31/01/2023

Sources of funding

Other

More details on funding

Utrecht University

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable