|D@n (Daniel Beldio)|
Nombre de messages : 3210
Age : 65
Localisation : Pays de l'Arbre et de l'Eau
Date d'inscription : 09/02/2007
|Sujet: Bonnes relations FDA - EMEA Mar 26 Jan - 17:28|| |
Article très intéressant :
Collaborations between the world’s leading medicines regulators have increased markedly in the last few years, a process which has come largely in response to the rapid globalisation of drug development, manufacturing and production.
In particular, the FDA is forging close links with its European Union counterpart the EMEA, and 2009 will see a number of new groundbreaking collaborations inaugurated.
Murray Lumpkin is the FDA’s Deputy Commissioner for International Programs, and is spearheading the FDA’s efforts in this field.
A physician specialising in paediatrics and tropical medicine, Lumpkin is an FDA veteran, having joined the agency 20 years ago, and has served under seven FDA Commissioners (plus numerous other temporary holders of the post).
Genial and happy to talk about all aspects of his work, Lumpkin nevertheless makes it clear that he cannot comment directly on the political aspects of the FDA's work, which is the preserve of the politically-appointed FDA Commissioners.
Speaking to Pharmafocus between sessions at the TOPRA regulatory affairs conference in Stockholm in October, Lumpkin explained the benefits of closer EU- American working and what it means for the industry. “This relationship is not new, it goes back 10-15 years, but over that time it has grown and progressed, and we have both got a lot out of it,” he says.
“Early on it was learning about each other's systems and so on, and then it progressed to how we could share information, because it got to the point where we were getting pretty much the same applications [from pharma companies].
“Of course in the US, nobody does the job we do – We’re the only FDA for the US, so we don't have peers. Then you realise you do have peers, it’s just that they are located in other parts of the world. And that is that the [FDA-EMEA] relationship has become, we really have become peers and friends, and sounding boards for each other.
“The good thing is that this dialogue extends beyond the top management level. It goes into the technical level in so many areas, which to me is the exciting part. A good example of that is the joint working groups or ‘clusters’ in, for example, oncology, paediatrics, pharmacogenetics, vaccines, veterinary medicine, and orphan medicines.”
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