After having already opened offices in China and India, the U.S. FDA has set up European Offices in Belgium (Brussels), the U.K. (London) and Italy (Parma). Dr Janice M. Soreth, Deputy Director of the Europe/US FDA, Liaison to EMEA, located in London, U.K. will now talk about the international programs of the FDA at the 4th QP Forum of the European QP Association on 3-4 December 2009 in Barcelona.
At the 3rd European GMP Conference in Heidelberg at the end of June, FDA's Thomas Arista explained that the FDA has to supervise more than 100,000 firms manufacturing products (e. g. food, medicinal products, medical devices) outside the US. The supervision of these products and manufacturers cannot be accomplished by the FDA alone. Therefore, it is the Agency's aim to strengthen the international co-operation. It is in this light, too, that the FDA sees the establishment of offices abroad. Thomas Arista recommended to the European industry to contact the local representatives in case of arising compliance questions. Their presence on site enables a direct and thus much quicker exchange of information than before.
On behalf of the European Qualified Person Association