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pro vyhledávání: '"Brigitte Casteels"'
Publikováno v:
Pharmaceuticals Policy & Law. 2001, Vol. 3 Issue 1, p69. 10p.
Autor:
Brigitte Casteels, Sebastian Rohde
Publikováno v:
Pharmaceuticals, Policy and Law. 15:85-92
The legal and regulatory system concerning medical devices is based on the three first European Union Directives, dated 1990, 1993 and 1998. Whereas most legislative areas commence with a ‘horizontal legislation’ covering all products generally,
Autor:
Rod S Taylor, Giuseppe Ambrosio, Angela Piazzi, Gian Franco Gensini, Brigitte Casteels, Marta Gehring, Marie Mellody
Publikováno v:
BMJ Open
Objectives: Applications to run clinical trials in Europe fell 25% between 2007 and 2011. Costs, speed of approvals and shortcomings of European Clinical Trial Directive are commonly invoked to explain this unsatisfactory performance. However, no har