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ISPE: International Pharmacoepidemiology Pharmacovigilance Legislation

by chuck_ltd | 18 Dec, 2015 | CHCUK News & Articles, News, NIS, Real Word Evidence, Registry

The conduct of pharmacoepidemiology studies are regulated by pharmacovigilance legislation which varies by region and country throughout the globe. These regulations and resulting definitions and requirements are summarised in guidance documents for study sponsors and...

EU: New Annex to the ENCePP Guide on Methodological Standards in Pharmacoepidemiology

by chuck_ltd | 18 Dec, 2015 | CHCUK News & Articles, News, NIS, Real Word Evidence, Registry

New ENCePP Guidance on Conducting Systematic Reviews and Meta-Analyses of Completed Comparative Pharmacoepidemiological Studies of Safety Outcomes Annex 1 to the ENCePP Guide on Methodological Standards in Pharmacoepidemiology was adopted by the ENCePP Steering Group...

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