Status: Finalised First registered on: 21/10/2019
Last updated on: 20/02/2020
1. Study identification
EU PAS Register NumberEUPAS31879
Official titleAbility of primary care health databases to assess medicinal products discussed by the European Union Pharmacovigilance Risk Assessment Committee
Study title acronymCAPs and NAPs in primary EHDs
Study typeObservational study
Brief description of the studyElectronic 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.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameEuropean Medicines Agency
Centre locationAmsterdam
Details of (Primary) lead investigator
Title Mr
Last name Flynn
First name Robert
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?2

CPRD
European Medicines Agency, Amsterdam
Countries in which this study is being conducted
International study

France
Germany
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed02/08/201902/08/2019
Start date of data collection02/08/201902/08/2019
Start date of data analysis
Date of interim report, if expected
Date of final study report17/10/201917/10/2019
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government bodyEMA and CPRD100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Mr
Last name Flynn
First name Robert
Address line 1European Medicines Agency
Address line 2Domenico Scarlattilaan 6 
Address line 3 
CityAmsterdam 
Postcode1083 HS 
CountryNetherlands
Phone number (incl. country code)31887818439 
Alternative phone number 
Fax number (incl. country code) 
Email address robert.flynn@ema.europa.eu
Public Enquiries
Title Mr 
Last name Kurz 
First name Xavier 
Address line 1European Medicines Agency 
Address line 2Domenico Scarlattilaan 6 
Address line 3 
CityAmsterdam 
Postcode1083 HS 
CountryNetherlands 
Phone number (incl. country code)31887817269 
Alternative phone number 
Fax number (incl. country code) 
Email address xavier.kurz@ema.europa.eu 
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