New approaches to fill the methods gap in pharmacovigilance

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28European Medicines Agengy conclusions
Struggles remainin observational drug-induced malignany research Hazard patterns: tumour initiation (5 yrs) , tumourpromotion (1 yr) Comparing users of drug A with users of drug B given thattreatment allocation is never random. (Longterm) exposure measurement and classification giventhe dynamics of diabetes treatment. The underlying disease (diabetes) is associated with theoutcome; insulin itself has also mitogenic characteristics. How to factor in relevant data on BMI, alcohol, smoking,etc?29
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 14 and 15: How to perform long-term follow-up?
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 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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