Amanda Maxwell, Editor
European Regulatory Affairs
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Portraiture: Kess Bohan & Salina Christmas |
As Clinica’s European regulatory affairs editor for nearly a quarter of a century, I continue to witness and record the increasingly complex regulation of ever more technically sophisticated products.
I cover the basic European Directives, regulations and other documents that emerge from the European Commission, follow the work of the Global Harmonisation Task Force, and keep an eye on the national regulators, particularly France.
I also monitor other regulations that impact the industry, such as borderline issues, environmental laws, standards, guidelines, and track funding and reimbursement issues. I particularly enjoy the close contact I have with key regulators at the European and within EU member states, and within the GHTF, and industry leaders. I love to follow how their insights stimulate new discussion and form proposals leading to new realities.
At present, I am particularly energised by the blue skies thinking that is going on at the European Commission and which has opened up a totally new dimension in thinking around the regulation of medtech products. These are controversial times.
