Ability of primary care health databases to assess medicinal products discussed by the European Union Pharmacovigilance Risk Assessment Committee (CAPs and NAPs in primary EHDs)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/33764
• EU PAS number:
  EUPAS31879
• Study ID:
  33764
• Official title and acronym:
  Ability of primary care health databases to assess medicinal products discussed by the European Union Pharmacovigilance Risk Assessment Committee (CAPs and NAPs in primary EHDs)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  United Kingdom
• Study description:
  Electronic primary care health databases are used by to assess the need for and the impact of post-licensing regulatory interventions. This study aims to measure the extent to which exposure to different categories of medicines, including centrally authorised products (CAPs) and nationally authorised products (NAPs), discussed by the Pharmacovigilance Risk Assessment Committee (PRAC) in a 3-month period (September-November 2019) was adequately covered in four electronic primary care health databases in their entire lifespan until 31 August 2018.
• Study status:
  Finalised

Research institution and networks

Institutions

European Medicines Agency (EMA)

Clinical Practice Research Datalink (CPRD)

United Kingdom

European Medicines Agency Amsterdam

Contact details

Robert Flynn

Study contact

[e-mail]

Robert Flynn

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned: 02/08/2019

Actual: 02/08/2019

Data collection

Planned: 02/08/2019

Actual: 02/08/2019

Date of final study report

Planned: 17/10/2019

Actual: 17/10/2019

Sources of funding

EMA

Other

More details on funding

CPRD

Regulatory

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