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9th International Conference and Exhibition on Pharmacovigilance & Drug Safety

Munich, Germany

Essam Ghanem

Essam Ghanem

Keyrus Biopharma, Belgium

Title: Risk management life cycle approach – key points


Biography: Essam Ghanem


The health authorities’ activities are targeting public health protection from the harm of used medicines, emphasizing their role in medicines risk assessment. Such achievement requires optimization of their collaboration with industry, addressing criticalities. The interactions with the involved stakeholders have a pivotal role where transparency during assessment of medicines’ benefit–risk profile throughout its life cycle should be ensured. Structured benefit/risk assessment framework earlier in drug development is challenging for medicinal products approval that necessitate positive benefit-risk balance parameters. At the end, the key question is “Do the health authorities’ interactions with patients and healthcare professionals have a beneficial impact on the taken decision”?

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