But while the European Medicines Agency has become the dominant regulatory body in Europe and a key player at world level, very few studies have investigated its actual practices. Based on interviews with European regulators, but also on direct observations of several meetings of the European ...
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As many as 30% of people living with severe hemophilia A develop inhibitors such as TFPI, which can be produced by the body’s immune response to clotting factors in replacement therapy, often limiting the effectiveness of that therapy.
To obtain an MAA in a tissue engineered product in Europe 100+ Health authority interactions per year >90% Consultants with a PhD/M.Sc/Pharm D. SOLUTIONS VCLS provides integrated solutions all along the development journey Preclinical Development ...
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Relationship between an effective dose of imatinib, body surface area, and trough drug levels in patients with chronic myeloid leukemia The standard dose of imatinib for the treatment of chronic-phase chronic myeloid leukemia (CML) is 400 mg/day. Some patients receive reduced doses of imati......
EU legislators must be “mindful” that any changes made to the EU orphan medicines framework and its incentive structure will impact drugmakers and patients for the next two decades, says Soraya Bekkali, head of Europe, Canada, and international at Alexion. ...
Regulatory body discussion papers acknowledge the future importance of personalised adaptive dosing19 but there is no clear guidance for these products. In both the US and EU, they are likely to be treated as products requiring detailed expert consultation and considered alongside the medicine’s mark...
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In the absence of a European harmonization directive, restrictions remain numerous. This chapter gives an overview of the different activities that are undertaken in Europe and outside and aimed at removing the barriers on intra-European trading or regulating this activity with a view of protecting ...