Sentence examples for post-authorization from inspiring English sources

"We did not intervene because we did not have to intervene," said Noel Walthion, head of the agency's office of post-authorization evaluation.

In July , 2002 observational post-authorization studies were subjected to regulation in Spain, giving rise to an uproar among sponsors and investigators.

This is a prospective, observational, multinational European post-authorization study among adults treated with onabotulinumtoxinA for CM headache prophylaxis.

There are two points in the transaction process where data is most vulnerable: pre- and post-authorization.

Hence, in total we found 50 post-authorization trials.

Its goal is to further strengthen the post-authorization monitoring of medicinal products in Europe by facilitating the conduct of multi-center, independent, post-authorization studies across Europe.

A two phases post authorization safety and effectiveness study of individuals vaccinated with the MF59-adjuvanted A/H1N1 influenza vaccine, Focetria® (Novartis Vaccines & Diagnostics, Siena, Italy), was conducted in Emilia-Romagna regItalyItaly during the 2009 A/H1N1 influenza pandemic.

Data on this is usually lacking at the time of authorization and is added to the label through post authorization SPC updates [ 25].

Multicenter, prospective, two-armed, post authorization study over 9 months in 14,200 patients with uncontrolled hypertension with and without the metabolic syndrome (doctors' diagnosis based on the Adult Treatment Panel III criteria 2001).

It was therefore the aim of the present analysis of the post authorization study Treat to Target to investigate in more detail the influence of the PPARγ activating ARB Irbesartan with or without HCTZ on metabolic parameters.

The study was submitted for validation in the Ethic Committee Hospital 12 de Octubre as stated in the Royal Decree 223/2004 and Article 58 of Law 29/2006 for Post Authorization Retrospective studies.