10. Guidelines for good pharmacoepidemiology practice
Guidelines for good pharmacoepidemiology practice
Guidelines for pharmacoepidemiologic research have been developed and disseminated by various organisations, such as the International Society for Pharmacoepidemiology (ISPE) and various regulatory agencies, such as the European Medicines Agency (EMA) and the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). Researchers conducting pharmacoepidemiologic studies should adhere to these guidelines to ensure that the research meets high quality standards for study design, implementation and reporting.
Links to various guidelines:
ISPE Guidelines for Good Pharmacoepidemiology Practices (GPP) https://www.pharmacoepi.org/resources/
- · EMA Guideline on good pharmacovigilance practices (GVP) Module VIII – Post-authorisation safety studies (Rev.1) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129137.pdf
The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance:
ENCePP seeks to promote and support high standards throughout the post-authorisation research process based on valid methodologies, transparency and scientific independence.
need for investigators to consistently consider methodological issues arising
in observational research resulted in the development of the ENCePP Checklist for
Study Protocols complemented by the ENCePP Guide on
Methodological Standards in Pharmacoepidemiology.
Both documents are referenced in Module VIII of the good pharmacovigilance practices (GVP) on post-authorisation safety studies (PASS) relating to authorised medicinal products, published by the European Medicines Agency (EMA).
» Checklist for Study Protocols Rev 4, dated October 2018
» Methodological Guide Rev 8 , dated July 2020