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●● Providing scientific advice in a regulatory

Vertaling van "technical scientific and regulatory " (Nederlands → Frans) :

Workshop on the Technical/Scientific and Regulatory Issues on the safety of tattoos, Body Piercing and Related Practices; European Commission, Ispra,VA,Italy 2003; 89-92.

Workshop on the Technical/Scientific and Regulatory Issues on the safety of tattoos, Body Piercing and Related Practices; European Commission, Ispra, VA, Italy 2003; 89-92.


Workshop on the Technical/Scientific and Regulatory Issues on the safety of tattoos, Body Piercing and Related Practices. European Commission, Ispra, VA, Italy 21-37.

Workshop on the Technical/Scientific and Regulatory Issues on the safety of tattoos, Body Piercing and Related Practices; European Commission, Ispra, VA, Italy 21-37.


Provision has been made for the organised exchange of information with the national scientific commissions which give final opinions (e.g. evaluation commissions for medicines) and with the representatives on the international scientific or regulatory committees (e.g. CHMP, CVMP, CMD(h), CMD(v), COMP, PDCO).

Provision has been made for the organised exchange of information with the national scientific commissions which give final opinions (e.g. evaluation commissions for medicines) and with the representatives on the international scientific or regulatory committees (e.g. CHMP, CVMP, CMD(h), CMD(v), COMP, PDCO).


Another significant activity is the provision of national scientific and technical regulatory advice.

Another significant activity is the provision of national scientific and technical regulatory advice.


Omnitrope, the pioneering biosimilar of the recombinant human growth hormone somatropin, has received regulatory approval as the first-ever biosimilar in Japan under the brand name Somatropin BS S.C. This approval paves the way for greater access to high-quality biopharmaceuticals in the world’s second-largest pharmaceuticals market and comes about three months after Japanese authorities published guidelines for a biosimilar regulatory pathway, which is based on similar scientific ...[+++]

Omnitrope, biosimilaire pionnier de la somatropine, une hormone de croissance humaine recombinante, a obtenu une autorisation au Japon sous la marque Somatropin BS S.C. Il s’agit du premier biosimilaire à avoir été homologué dans ce pays.


Selected projects awaiting regulatory decisions Completed submissions Product Indication US EU Japan News update ABF656 Hepatitis C Q4 2009 - EU submission withdrawn in April 2010 for technical reasons

Projets pharmaceutiques importants en attente de décisions réglementaires Demandes déposées Produit Indication USA UE Japon Mise à jour ABF656 Hépatite C T4 2009 - Retrait en avril 2010 de la soumission dans l’UE pour des raisons techniques Exelon Patch Maladie Autorisé Autorisé T1 2010 d’Alzheimer


A great amount of preparation has also been focused on the creation of a scientific/technical council which will function as a scientific consultation platform.

A great amount of preparation has also been focused on the creation of a scientific/technical council which will function as a scientific consultation platform.


● Providing scientific advice in a regulatory

● Providing scientific advice in a regulatory


To raise Belgium’s profile even further in the European context, regulatory and scientific expertise needs to carry on being developed, and the quality of the services delivered needs to be monitored and improved continuously.

To raise Belgium’s profile even further in the European context, regulatory and scientific expertise needs to carry on being developed, and the quality of the services delivered needs to be monitored and improved continuously.


Currently, a project to establish a “Scientific – technical council” in the context of the CTTF is being discussed, which would act as a discussion forum between the relevant FAMHP department and the Ethics Committees.

Currently, a project to establish a “Scientific – technical council” in the context of the CTTF is being discussed, which would act as a discussion forum between the relevant FAMHP department and the Ethics Committees.




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Date index: 2022-06-19
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