Can We Rely on Results From IQVIA Medical Research Data UK Converted to the Observational Medical Outcome Partnership Common Data Model?

Author:

Candore Gianmario1,Hedenmalm Karin1,Slattery Jim2,Cave Alison2,Kurz Xavier2,Arlett Peter2

Affiliation:

1. Business Data Department European Medicines Agency Amsterdam The Netherlands

2. Pharmacovigilance and Epidemiology Department European Medicines Agency Amsterdam The Netherlands

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference41 articles.

1. Real‐World Data for Regulatory Decision Making: Challenges and Possible Solutions for Europe

2. European Commission.Guideline on the format and content of applications for designation as orphan medicinal products and on the transfer of designations from one sponsor to another 27.03.2014.Belgium:European Commission Health and Consumers Directorate‐General (2014).

3. European Medicines Agency.Orphan designation: Overview.

4. An Evaluation of the THIN Database in the OMOP Common Data Model for Active Drug Safety Surveillance

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