Measuring the impact of medicines regulatory interventions - Systematic review and methodological considerations

Author:

Goedecke Thomas1ORCID,Morales Daniel R.12,Pacurariu Alexandra13,Kurz Xavier1

Affiliation:

1. Pharmacovigilance and Epidemiology Department, Inspections Human Medicines Pharmacovigilance and Committees Division; European Medicines Agency (EMA); London E14 5EU UK

2. Division of Population Health Sciences; University of Dundee; Dundee DD2 4BF UK

3. Dutch Medicines Evaluation Board; 3531 AH Utrecht The Netherlands

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference172 articles.

1. Epidemiology of adverse drug reactions in Europe: a review of recent observational studies;Bouvy;Drug Saf,2015

2. Proactively managing the risk of marketed drugs: experience with the EMA Pharmacovigilance risk assessment committee;Arlett;Nat Rev Drug Discov,2014

3. Pharmacovigilance Risk Assessment Committee PRAC strategy on measuring the impact of pharmacovigilance activities (Rev 1) (EMA/165407/2017) 2017 http://www.ema.europa.eu/docs/en_GB/document_library/Other/2016/01/WC500199756.pdf

4. Coglianese C Measuring regulatory performance. Evaluating the impact of regulation and policy. Organisation for Economic Co-operation and Development (OECD) http://www.oecd.org/gov/regulatory-policy/1_coglianese%20web.pdf

5. Fifty years of pharmacovigilance - medicines safety and public health;Laporte;Pharmacoepidemiol Drug Saf,2016

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