Status: Planned First registered on: 13/11/2019
Last updated on: 18/11/2019
1. Study identification
EU PAS Register NumberEUPAS32302
Official titleEvaluation of the effectiveness of pregnancy prevention programme (PPP) for oral retinoids (acitretin, alitretinoin, and isotretinoin): a European before-after drug utilization study (DUS) using secondary data
Study title acronym
Study typeOther: Drug Utilization Study
Brief description of the study
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 1 (imposed as condition of marketing authorisation)
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 to which the investigator belongsIQVIA
Department/Research groupReal World Solutions
Organisation/affiliationIQVIA
Website/Homepagehttps://www.iqvia.com/
Details of (Primary) lead investigator
Title Dr
Last name Toussi
First name Massoud
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
International study

France
Germany
Spain
Sweden
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed30/06/2018
Start date of data collection01/07/2021
Start date of data analysis
Date of interim report, if expected
Date of final study report31/12/2022
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesOral Retinoids Consortium consisting of 31 Marketing Authorisation Holders100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Toussi
First name Massoud
Address line 1Tour D2
Address line 217 bis Place des Reflets 
Address line 3 
CityCourbevoie 
Postcode92090 
CountryFrance
Phone number (incl. country code)0033607966650 
Alternative phone number 
Fax number (incl. country code) 
Email address massoud.toussi@iqvia.com
Public Enquiries
Title Ms 
Last name Dwan 
First name Bernadette 
Address line 1Theaterstrasse 4 
Address line 2 
Address line 3 
CityBasel 
Postcode 
CountrySwitzerland 
Phone number (incl. country code)0041754335843 
Alternative phone number 
Fax number (incl. country code) 
Email address bernadette.dwan@iqvia.com 
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