New approaches to fill the methods gap in pharmacovigilance

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How to perform long-term follow-up?build a registry Clinicaltrials.gov (July 16, 2010) Observational registry n=553 Obvservational registry long-term n=92• Drug n=24• Drug+comparator n=6• Disease n=23• Device n=21• Cell therapy n=2• Procedure n=16Disease registriesD:A:D Data collection on Adverse events of anti-HIV DrugsTNF inhibitor users (British Society of Rheumatology)UK epilepsy and Pregnancy RegisterThe Hunter outcomes Survey (set up by idursulphase company)14
From single-product to disease-basedregistries?15Askling J. ENCePP Scientific Convention ‘EU health care databases for pan-EUpharmacoepidemiological research’, London, 25 November 2008.
Page 5: The pharmacovigilance ‘tool kit
Page 8 and 9: European Medicines Agency prioritie
Page 10 and 11: 10Struggle 1: long-term adverse eff
Page 12 and 13: Benefit-risk balance at time of app
Page 16 and 17: Limitations of registries Comparato
Page 18 and 19: Studying long-term effects in datab
Page 20 and 21: 20Struggle 2: drug-induced malignan
Page 22 and 23: 22Struggle 2: drug-induced malignan
Page 24 and 25: Insuline glargine and cancer risk 4
Page 26 and 27: Investors are reacting promptly tor
Page 28 and 29: 28European Medicines Agengy conclus
Page 30 and 31: 30Take home messages
Page 32 and 33: Take home messages Active risk mana
Page 34: 34Thank you for your attention

New approaches to fill the methods gap in pharmacovigilance

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